Pain, PostoperativePhase 4NCT04495374
Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy
A Phase 4 study testing Pregabalin 300mg in people with Pain, Postoperative and Analgesia, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial summary
Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms resulting from surgery. It impairs the recovery of patient since it is related to chronic pain, nausea and vomiting and longer hospital stay, generating higher cost to the health system. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative, Analgesia, Gabapentin Adverse Reaction
- What is being tested?
- Pregabalin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Sep 2019to 30 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo elective abdominal hysterectomy surgery due to benign pathologies;
- Be classified as physical status by the Society of Anesthesiologists (ASA) as ASA I (healthy individual) or ASA II (patient with mild and controlled systemic disease);
Who cannot join
- Allergy or intolerance previously known to pregabalin or opioids;
- Patients with chronic pain or fibromyalgia;
- Patients on chronic opioid use;
- Carriers of malignant neoplasms;
- Pregnant women;
- People with active uncontrolled cardiovascular disease;
Show all 10Show fewer
- Patients with kidney and / or liver disease;
- Patients who have spinal deformities that make spinal anesthesia impossible;
- Presence of coagulation disorders or anticoagulant therapy that cannot be suspended for surgery;
- Presence of active sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption
Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms resulting from surgery. It impairs the recovery of patient since it is related to chronic pain, nausea and vomiting and longer hospital stay, generating higher cost to the health system. Thus, the use of new methods to control postoperative pain is recommended and multimodal analgesia, an opioid-sparing strategies, has been widely used by several researchers. Studies show that gabapentins have beneficial effects on postoperative pain control when used as pre-anesthetic medication, also showing a reduction in opioid consumption, with few adverse effects. Among gynecological surgeries, abdominal hysterectomy is one of the procedures that generates the highest degree of acute postoperative pain. Thus, the aim of the present study is to investigate the effect of oral pregabalin (300 mg) two hours before abdominal hysterectomy procedures on postoperative pain. This study is a randomized, double-blind, placebo controlled clinical trial. Patients submitted to abdominal hysterectomy for benign pathologies will be selected and divided into two groups: the placebo controlled group (P0) and the pregabalin 300 mg group (P1). Group P0 will receive a placebo tablet one hour before the procedure, while group P1 will receive a 300 mg tablet of pregabalin identical to the placebo tablet. The reduction of postoperative pain and the best quality of patient recovery will be evaluated using the Visual Analogue Pain Scale (VAS) and the McGill Pain Questionnaire. Also, it will be evaluated the consumption of opioids as a rescue analgesic medication and the presence of adverse effects such as nausea and vomiting.
Read the detailed description
The sample population of this study is 102 female patients (50 already included in the study), who have undergone abdominal hysterectomy surgery for benign conditions, with or without joint oophorectomy / salpingectomy. The patients received spinal anesthesia, at hospital "Santa Casa de Alfenas" - Minas Gerais / Brazil ("Casa de Caridade Nossa Senhora do Perpétuo Socorro"). All surgeries were performed by the same team of surgeons.
All patients were evaluated and followed from the preoperative period, up to 24 hours postoperatively, passing through the intraoperative period. During all stages, patients were assisted by a properly trained multi-professional team, consisting of a doctor, nurse and nursing technician.
For the patient to be included in the study, she must have understood and agreed with the informed consent form that was explained in detail to all possible candidates in the preoperative period.
This is a double blind randomized study. The patients were randomly allocated to 02 groups, in which Group 1 received medication A (designated in the study as medication 1), whereas Group 2 received medication B (designated in the study as medication 2).
Study participants and researchers were blinded as to the use of drug / placebo to avoid measurement bias. To carry out the blinding process, an external researcher was assigned to randomize the groups and prepare the pills in opaque and closed envelopes characterized only by a control identification (A or B), which is known only to this researcher. Patients in both groups received identical sealed envelopes, 02h before the start of the anesthetic procedure, only identified as medication A or B, which contained two pills in each envelope. A second researcher is responsible for collecting data and monitoring the patient from the intraoperative period up to 24 hours after discharge from the post-anesthetic recovery room (PARR).
In the operating room, venoclysis was performed with jelco No. 18 or No. 20, and an infusion of 08 ml.kg-1 of crystalloid solution (lactated ringer). The patients were properly monitored with pulse oximetry, cardioscope, and non-invasive blood pressure monitor. After monitoring, patients were premedicated with intravenous (IV) midazolam at a dosage of 0.03 mg.kg1.
To perform spinal anesthesia, the patients were seated on the surgical stretcher by the nursing team. Asepsis and antisepsis were performed at the puncture site with alcoholic chlorhexidine solution. After placement of sterile drapes, local anesthesia was performed with 2.0% lidocaine without vasoconstrictor. The first attempt at subarachnoid puncture was performed, using the median technique, between the intervertebral levels L3-L4 or L4-L5 or L5-S1, with a 25 gauge Quincke needle for subarachnoid anesthesia. If there was a technical difficulty in the puncture, the paramedian puncture technique was chosen. The confirmation of the correct puncture was based on the aspiration of cerebrospinal fluid. Anesthesia was performed with the local anesthetic 0.5% bupivacaine at a dosage of 0.3 mg.kg-1, injected from a 5 ml disposable syringe. After anesthesia, the patients were placed in the supine position, and the correct level of anesthesia was proven with thermal sensitivity tests using cotton soaked with alcoholic solution. After the anesthesia reached the sensory level of the T4 thoracic vertebra, the surgical team was allowed to start the procedure. Prior to the beginning of the surgical incision, a delayed bladder probe was performed in all patients according to the surgeon's indication.
Hemodynamic changes in blood pressure were controlled with the use of vasoactive medications such as ephedrine or metaraminol. For prophylaxis of postoperative nausea and vomiting (PONV) ondansetron was administered at a dosage of 4 mg intravenously (IV) 30 minutes before the end of surgery. Tenoxicam was prescribed for all patients at a dosage of 20 mg IV at regular intervals every 12 hours for the purpose of anti-inflammatory and analgesic action. For analgesic relief, dipyrone IV was also prescribed at a dosage of 50 mg.kg-1 at regular intervals every 6 hours. During the surgery, and also at the end of the surgery, the patients were evaluated for the degree of sedation using the Ramsay sedation scale as a basis.
At the end of the surgery, the patients were referred to the post-anaesthesia care unit, where they were monitored again, and went through the pain assessment process using the visual analog scale (VAS) in relation to pain at rest and "movement" (the patient was asked to perform the forced cough movement), through a direct question with scale demonstration. Pains characterized as mild (0 - 2 VAS) received no medication other than those already prescribed; pain characterized as moderate (3 - 7 EVA) received IV morphine at a dosage of 0.025 mg.kg-1; and severe pain (8 - 10 VAS) received IV morphine at a dose of 0.05 mg.kg-1 every 01 h until analgesic control.
To consider themselves able to be discharged from the post-anaesthesia care unit for clinical follow-up in wards, patients should reach a score ≥ 9 on the modified Aldrete Scale and have VAS pain scores ≤ 2.
In the infirmary, patients were tested at regular intervals for pain intensity, by of a team of nurses trained and qualified to do so. The patients had pain classified as moderate (VAS ≥ 2 <8) or severe (VAS ≥ 8), receiving drugs with morphine IV in the dose of 1 mg and 2 mg respectively, according to the medical prescription.
24 h after discharge from the post-anaesthesia care unit, in the ward, all the patient was assessed by the same examiner who performed an assessment at the post-anaesthesia care unit, who stratified the patient again from the EVA and assessed using the McGill questionnaire.
During the entire hospitalization period, the use of central nervous system (CNS) depressant drugs (example: ketamine, droperidol, promethazine) and / or analgesic drugs that do not contain any study protocol was avoided. If some patients were medicated with these drugs, they were excluded from the study.
The data related to surgery (pre, trans and postoperative) were collected for statistical analysis, according to Annex II, in which a total duration of surgery in minutes; the total intravenous medication infused; the values of mean arterial pressure and heart rate in the pre, intra and postoperative period; a presence or not, as well as a quantity, of PONV in the post-anaesthesia care unit and after 24h; presence or not of dizziness as a possible side effect; among others.
All data selected through the study will be digitized and analyzed using the Statistic® 7.0 software. The data will be compared using repeated measures ANOVA, followed by Newman-Keuls post-hoc, being considered for p <0.05.
- Being tested
- Pregabalin 300mg, Placebo
- Keywords
- postoperative pain, multimodal analgesia, pregabalin, preemptive analgesia, abdominal hysterectomy, gabapentins
- Medical subject headings
- Pain, Postoperative, Agnosia, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 300mgDrug
Also called Preemptive analgesia
Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
PlaceboOther
Also called Controls
Group P0 will receive a placebo tablet, 02h before the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Group P(0) - Placebo | Placebo comparator | Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B Receives: Other: Placebo |
| Group P(1) - Pregabalin 300mg | Experimental | Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B Receives: Drug: Pregabalin 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative Pain Assessed 24 Hours After Abdominal Hysterectomy Surgery, Using the McGill Pain Questionnaire
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single 300mg dose of pregabalin or placebo as preemptive analgesia, using the McGill pain questionnaire, which consists of 20 word groups , and each group can contain from 2 to 6 descriptive words, these descriptors are placed in an increasing order of magnitude in relation to the intensity. The left of each word has a numerical value in an attempt to represent the intensity of the descriptor. For the analysis of the answers, the total number of words chosen in each subgroup by the patient was used to qualify his pain, the minimum value being equal to 0 (zero), if the patient chose not to choose any descriptor, and the maximum value would be 20, as the patient can choose only one descriptor for each subgroup. The quantitative pain index was also evaluated, which represents the sum of the values of each descriptor chosen by the patient, with a minimum value of 0 and a maximum of 78.
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative Pain in Active Movement Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Secondary outcomes (3)
Number of Doses of Opioids Used as Analgesic Rescue in the Postoperative Period
Evaluation of the number of intravenous opioid doses used within 24 hours of postoperative abdominal hysterectomy surgery in patients who used pregabalin 300mg or not as preemptive analgesia
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Time Required for the Use of the First Dose of Opioid as an Analgesic Rescue in the Postoperative Period
- Evaluation of the time between the end of abdominal hysterectomy surgery and the patient's request for the use of the first dose of intravenous opioid as an analgesic rescue, comparing between patients who used or not pregabalin 300mg as preemptive analgesia
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Number of Participants With Dizziness Between the Intervention and Control Groups
- Assess the presence of adverse effects such as nausea and vomiting, itching and dizziness, comparing the intervention group that used pregabalin with the placebo group
Measured: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery) and also immediately in the post-anesthetic recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start2 Sep 2019
- Primary completion9 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Due to an atypical health scenario caused by the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larissa Helena Lobo Torres Pacheco, Universidade Federal de Alfenas
- Investigators
- Larissa H Torres, PhD, Principal investigator, Universidade Federal de AlfenasFabrício G Silva, BSc, Study chair, Santa Casa de AlfenasCarlos M de Barros, BSc, Study chair, Universidade Federal de AlfenasMarcia H Podestá, PhD, Study chair, Universidade Federal de AlfenasCarla S Ceron, PhD, Study chair, Universidade Federal de AlfenasThayná C Silva, BSc, Study chair, Santa Casa de AlfenasDenismar A Nogueira, PhD, Study chair, Universidade Federal de AlfenasTiago M Reis, PhD, Study chair, Universidade Federal de Alfenas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495374
- Sponsor's protocol ID
- 3.334.050
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2020
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.
PubMed 30519075As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
PubMed 29112660Farzi F, Naderi Nabi B, Mirmansouri A, Fakoor F, Atrkar Roshan Z, Biazar G, Zarei T. Postoperative Pain After Abdominal Hysterectomy: A Randomized, Double-Blind, Controlled Trial Comparing the Effects of Tramadol and Gabapentin as Premedication. Anesth Pain Med. 2016 Jan 17;6(1):e32360. doi: 10.5812/aapm.32360. eCollection 2016 Feb.
PubMed 27110531Ghai A, Gupta M, Hooda S, Singla D, Wadhera R. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy. Saudi J Anaesth. 2011 Jul;5(3):252-7. doi: 10.4103/1658-354X.84097.
PubMed 21957402Kohli M, Murali T, Gupta R, Khan P, Bogra J. Optimization of subarachanoid block by oral pregabalin for hysterectomy. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):101-5.
PubMed 21804717Main CJ. Pain assessment in context: a state of the science review of the McGill pain questionnaire 40 years on. Pain. 2016 Jul;157(7):1387-1399. doi: 10.1097/j.pain.0000000000000457.
PubMed 26713423Steinberg AC, Schimpf MO, White AB, Mathews C, Ellington DR, Jeppson P, Crisp C, Aschkenazi SO, Mamik MM, Balk EM, Murphy M. Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines. Am J Obstet Gynecol. 2017 Sep;217(3):303-313.e6. doi: 10.1016/j.ajog.2017.03.013. Epub 2017 Mar 27.
PubMed 28351670Tulandi T, Krishnamurthy S, Mansour F, Suarthana E, Al-Malki G, Ballesteros LER, Moore A. A Triple-Blind Randomized Trial of Preemptive Use of Gabapentin Before Laparoscopic Hysterectomy for Benign Gynaecologic Conditions. J Obstet Gynaecol Can. 2019 Sep;41(9):1282-1288. doi: 10.1016/j.jogc.2018.11.019. Epub 2019 Jan 25.
PubMed 30686609Verret M, Lauzier F, Zarychanski R, Savard X, Cossi MJ, Pinard AM, Leblanc G, Turgeon AF. Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis. Syst Rev. 2019 Jan 16;8(1):24. doi: 10.1186/s13643-018-0906-3.
PubMed 30651123Yucel A, Ozturk E, Aydogan MS, Durmus M, Colak C, Ersoy MO. Effects of 2 different doses of pregabalin on morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind clinical trial. Curr Ther Res Clin Exp. 2011 Aug;72(4):173-83. doi: 10.1016/j.curtheres.2011.06.004.
PubMed 24648587
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption
- ClinicalTrials.gov ID
- NCT04495374
- Acronym / sponsor ID
- 3.334.050
- Keywords
- postoperative pain, multimodal analgesia, pregabalin, preemptive analgesia, abdominal hysterectomy, gabapentins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to an atypical health scenario caused by the COVID-19 pandemic
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 4 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms resulting from surgery. It impairs the recovery of patient since it is related to chronic pain, nausea and vomiting and longer hospital stay, generating higher cost to the health system. Thus, the use of new methods to control postoperative pain is recommended and multimodal analgesia, an opioid-sparing strategies, has been widely used by several researchers. Studies show that gabapentins have beneficial effects on postoperative pain control when used as pre-anesthetic medication, also showing a reduction in opioid consumption, with few adverse effects. Among gynecological surgeries, abdominal hysterectomy is one of the procedures that generates the highest degree of acute postoperative pain. Thus, the aim of the present study is to investigate the effect of oral pregabalin (300 mg) two hours before abdominal hysterectomy procedures on postoperative pain. This study is a randomized, double-blind, placebo controlled clinical trial. Patients submitted to abdominal hysterectomy for benign pathologies will be selected and divided into two groups: the placebo controlled group (P0) and the pregabalin 300 mg group (P1). Group P0 will receive a placebo tablet one hour before the procedure, while group P1 will receive a 300 mg tablet of pregabalin identical to the placebo tablet. The reduction of postoperative pain and the best quality of patient recovery will be evaluated using the Visual Analogue Pain Scale (VAS) and the McGill Pain Questionnaire. Also, it will be evaluated the consumption of opioids as a rescue analgesic medication and the presence of adverse effects such as nausea and vomiting.
Detailed description
The sample population of this study is 102 female patients (50 already included in the study), who have undergone abdominal hysterectomy surgery for benign conditions, with or without joint oophorectomy / salpingectomy. The patients received spinal anesthesia, at hospital "Santa Casa de Alfenas" - Minas Gerais / Brazil ("Casa de Caridade Nossa Senhora do Perpétuo Socorro"). All surgeries were performed by the same team of surgeons.
All patients were evaluated and followed from the preoperative period, up to 24 hours postoperatively, passing through the intraoperative period. During all stages, patients were assisted by a properly trained multi-professional team, consisting of a doctor, nurse and nursing technician.
For the patient to be included in the study, she must have understood and agreed with the informed consent form that was explained in detail to all possible candidates in the preoperative period.
This is a double blind randomized study. The patients were randomly allocated to 02 groups, in which Group 1 received medication A (designated in the study as medication 1), whereas Group 2 received medication B (designated in the study as medication 2).
Study participants and researchers were blinded as to the use of drug / placebo to avoid measurement bias. To carry out the blinding process, an external researcher was assigned to randomize the groups and prepare the pills in opaque and closed envelopes characterized only by a control identification (A or B), which is known only to this researcher. Patients in both groups received identical sealed envelopes, 02h before the start of the anesthetic procedure, only identified as medication A or B, which contained two pills in each envelope. A second researcher is responsible for collecting data and monitoring the patient from the intraoperative period up to 24 hours after discharge from the post-anesthetic recovery room (PARR).
In the operating room, venoclysis was performed with jelco No. 18 or No. 20, and an infusion of 08 ml.kg-1 of crystalloid solution (lactated ringer). The patients were properly monitored with pulse oximetry, cardioscope, and non-invasive blood pressure monitor. After monitoring, patients were premedicated with intravenous (IV) midazolam at a dosage of 0.03 mg.kg1.
To perform spinal anesthesia, the patients were seated on the surgical stretcher by the nursing team. Asepsis and antisepsis were performed at the puncture site with alcoholic chlorhexidine solution. After placement of sterile drapes, local anesthesia was performed with 2.0% lidocaine without vasoconstrictor. The first attempt at subarachnoid puncture was performed, using the median technique, between the intervertebral levels L3-L4 or L4-L5 or L5-S1, with a 25 gauge Quincke needle for subarachnoid anesthesia. If there was a technical difficulty in the puncture, the paramedian puncture technique was chosen. The confirmation of the correct puncture was based on the aspiration of cerebrospinal fluid. Anesthesia was performed with the local anesthetic 0.5% bupivacaine at a dosage of 0.3 mg.kg-1, injected from a 5 ml disposable syringe. After anesthesia, the patients were placed in the supine position, and the correct level of anesthesia was proven with thermal sensitivity tests using cotton soaked with alcoholic solution. After the anesthesia reached the sensory level of the T4 thoracic vertebra, the surgical team was allowed to start the procedure. Prior to the beginning of the surgical incision, a delayed bladder probe was performed in all patients according to the surgeon's indication.
Hemodynamic changes in blood pressure were controlled with the use of vasoactive medications such as ephedrine or metaraminol. For prophylaxis of postoperative nausea and vomiting (PONV) ondansetron was administered at a dosage of 4 mg intravenously (IV) 30 minutes before the end of surgery. Tenoxicam was prescribed for all patients at a dosage of 20 mg IV at regular intervals every 12 hours for the purpose of anti-inflammatory and analgesic action. For analgesic relief, dipyrone IV was also prescribed at a dosage of 50 mg.kg-1 at regular intervals every 6 hours. During the surgery, and also at the end of the surgery, the patients were evaluated for the degree of sedation using the Ramsay sedation scale as a basis.
At the end of the surgery, the patients were referred to the post-anaesthesia care unit, where they were monitored again, and went through the pain assessment process using the visual analog scale (VAS) in relation to pain at rest and "movement" (the patient was asked to perform the forced cough movement), through a direct question with scale demonstration. Pains characterized as mild (0 - 2 VAS) received no medication other than those already prescribed; pain characterized as moderate (3 - 7 EVA) received IV morphine at a dosage of 0.025 mg.kg-1; and severe pain (8 - 10 VAS) received IV morphine at a dose of 0.05 mg.kg-1 every 01 h until analgesic control.
To consider themselves able to be discharged from the post-anaesthesia care unit for clinical follow-up in wards, patients should reach a score ≥ 9 on the modified Aldrete Scale and have VAS pain scores ≤ 2.
In the infirmary, patients were tested at regular intervals for pain intensity, by of a team of nurses trained and qualified to do so. The patients had pain classified as moderate (VAS ≥ 2 <8) or severe (VAS ≥ 8), receiving drugs with morphine IV in the dose of 1 mg and 2 mg respectively, according to the medical prescription.
24 h after discharge from the post-anaesthesia care unit, in the ward, all the patient was assessed by the same examiner who performed an assessment at the post-anaesthesia care unit, who stratified the patient again from the EVA and assessed using the McGill questionnaire.
During the entire hospitalization period, the use of central nervous system (CNS) depressant drugs (example: ketamine, droperidol, promethazine) and / or analgesic drugs that do not contain any study protocol was avoided. If some patients were medicated with these drugs, they were excluded from the study.
The data related to surgery (pre, trans and postoperative) were collected for statistical analysis, according to Annex II, in which a total duration of surgery in minutes; the total intravenous medication infused; the values of mean arterial pressure and heart rate in the pre, intra and postoperative period; a presence or not, as well as a quantity, of PONV in the post-anaesthesia care unit and after 24h; presence or not of dizziness as a possible side effect; among others.
All data selected through the study will be digitized and analyzed using the Statistic® 7.0 software. The data will be compared using repeated measures ANOVA, followed by Newman-Keuls post-hoc, being considered for p <0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P(0) - Placebo | Placebo comparator | Other: PlaceboPatients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B |
| Group P(1) - Pregabalin 300mg | Experimental | Drug: Pregabalin 300mgPatients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo elective abdominal hysterectomy surgery due to benign pathologies;
- Be classified as physical status by the Society of Anesthesiologists (ASA) as ASA I (healthy individual) or ASA II (patient with mild and controlled systemic disease);
Key exclusion criteria (10 listed)
- Allergy or intolerance previously known to pregabalin or opioids;
- Patients with chronic pain or fibromyalgia;
- Patients on chronic opioid use;
- Carriers of malignant neoplasms;
- Pregnant women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 300mgAlso: Preemptive analgesiaGroup P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure | Drug | Group P(1) - Pregabalin 300mg |
| PlaceboAlso: ControlsGroup P0 will receive a placebo tablet, 02h before the surgical procedure | Other | Group P(0) - Placebo |
Primary outcome
Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Postoperative Pain Assessed 24 Hours After Abdominal Hysterectomy Surgery, Using the McGill Pain Questionnaire
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single 300mg dose of pregabalin or placebo as preemptive analgesia, using the McGill pain questionnaire, which consists of 20 word groups , and each group can contain from 2 to 6 descriptive words, these descriptors are placed in an increasing order of magnitude in relation to the intensity. The left of each word has a numerical value in an attempt to represent the intensity of the descriptor. For the analysis of the answers, the total number of words chosen in each subgroup by the patient was used to qualify his pain, the minimum value being equal to 0 (zero), if the patient chose not to choose any descriptor, and the maximum value would be 20, as the patient can choose only one descriptor for each subgroup. The quantitative pain index was also evaluated, which represents the sum of the values of each descriptor chosen by the patient, with a minimum value of 0 and a maximum of 78.
Postoperative Pain in Active Movement Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
3 secondary outcomes
Number of Doses of Opioids Used as Analgesic Rescue in the Postoperative Period
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Time Required for the Use of the First Dose of Opioid as an Analgesic Rescue in the Postoperative Period
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
Number of Participants With Dizziness Between the Intervention and Control Groups
Time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery) and also immediately in the post-anesthetic recovery room
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30519075Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.
- Background: PubMed 29112660As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
- Background: PubMed 27110531Farzi F, Naderi Nabi B, Mirmansouri A, Fakoor F, Atrkar Roshan Z, Biazar G, Zarei T. Postoperative Pain After Abdominal Hysterectomy: A Randomized, Double-Blind, Controlled Trial Comparing the Effects of Tramadol and Gabapentin as Premedication. Anesth Pain Med. 2016 Jan 17;6(1):e32360. doi: 10.5812/aapm.32360. eCollection 2016 Feb.
- Background: PubMed 21957402Ghai A, Gupta M, Hooda S, Singla D, Wadhera R. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy. Saudi J Anaesth. 2011 Jul;5(3):252-7. doi: 10.4103/1658-354X.84097.
- Background: PubMed 21804717Kohli M, Murali T, Gupta R, Khan P, Bogra J. Optimization of subarachanoid block by oral pregabalin for hysterectomy. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):101-5.
- Background: PubMed 26713423Main CJ. Pain assessment in context: a state of the science review of the McGill pain questionnaire 40 years on. Pain. 2016 Jul;157(7):1387-1399. doi: 10.1097/j.pain.0000000000000457.
- Background: PubMed 28351670Steinberg AC, Schimpf MO, White AB, Mathews C, Ellington DR, Jeppson P, Crisp C, Aschkenazi SO, Mamik MM, Balk EM, Murphy M. Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines. Am J Obstet Gynecol. 2017 Sep;217(3):303-313.e6. doi: 10.1016/j.ajog.2017.03.013. Epub 2017 Mar 27.
- Background: PubMed 30686609Tulandi T, Krishnamurthy S, Mansour F, Suarthana E, Al-Malki G, Ballesteros LER, Moore A. A Triple-Blind Randomized Trial of Preemptive Use of Gabapentin Before Laparoscopic Hysterectomy for Benign Gynaecologic Conditions. J Obstet Gynaecol Can. 2019 Sep;41(9):1282-1288. doi: 10.1016/j.jogc.2018.11.019. Epub 2019 Jan 25.
- Background: PubMed 30651123Verret M, Lauzier F, Zarychanski R, Savard X, Cossi MJ, Pinard AM, Leblanc G, Turgeon AF. Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis. Syst Rev. 2019 Jan 16;8(1):24. doi: 10.1186/s13643-018-0906-3.
- Background: PubMed 24648587Yucel A, Ozturk E, Aydogan MS, Durmus M, Colak C, Ersoy MO. Effects of 2 different doses of pregabalin on morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind clinical trial. Curr Ther Res Clin Exp. 2011 Aug;72(4):173-83. doi: 10.1016/j.curtheres.2011.06.004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa H Torres, PhD principal investigator
Universidade Federal de Alfenas
Fabrício G Silva, BSc study chair
Santa Casa de Alfenas
Carlos M de Barros, BSc study chair
Universidade Federal de Alfenas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 300mg in people with Pain, Postoperative and Analgesia, run by Universidade Federal de Alfenas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS) (time frame: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04495374, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.