Pain, PostoperativeNCT03583892
Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy
An observational study of Pain, Postoperative, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial summary
The multimodal analgesia involves the administration of two or more analgesic agents that exert their effects via different analgesic mechanisms, providing superior analgesia with fewer side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2018to Jul 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic cholecystectomy in the "Centro Hospitalar do Porto".
Who may be able to join
- Patients belonging to American Society of Anesthesiologists physical status I and II;
- Patients undergoing elective laparoscopic cholecystectomy, under general anesthesia;
- Age between 18 and 75 years;
- Patients hemodynamically stable.
Who cannot join
- Patients with an age older than 75 years or younger than 18 years;
- Uncontrolled concomitant medical diseases (hypertension, bronchial asthma, diabetes mellitus);
- Patients with history of chronic pain conditions;
- Impaired kidney or liver function;
- History of drug or alcohol abuse;
- Occurrence of surgical complications that force a change in the established surgical approach;
- Administration of analgesics within 24 hours of scheduled surgery;
- Patients already on gabapentin or other anticonvulsants.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Porto
Porto, 4099-001
Serviço de Anestesiologia
Rita Saraiva, MD
About this study
The multimodal analgesia involves the administration of two or more analgesic agents that exert their effects via different analgesic mechanisms, providing superior analgesia with fewer side effects. This multimodal analgesic regimen includes opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and peripheral nerve blocks. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol.
Read the detailed description
Postoperative pain after laparoscopic cholecystectomy is not only nociceptive but also inflammatory, neurogenic and visceral. Therefore, because of involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. The multimodal analgesic mechanisms include opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and transversus abdominis plane block. Pre-treatment with gabapentin blocks the development of hyperalgesia and tactile allodynia for up to two days. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol. In the preoperative period, consent is requested for patients who meet the inclusion criteria of the study. At this time it is verified whether gabapentin has been prescribed by the attending physician or not. If enrolled, the patient is allocated to the gabapentin group (Group A) or to the non-gabapentin group (Group B), according to his/her prescription.
All patients are monitored for electrocardiogram, pulse oximetry, noninvasive blood pressure, capnography, bispectral index (BIS®), and neuromuscular transmission with Train-of-Four (TOF®) during intraoperative period. Anesthesia is induced with intravenous fentanyl 1 to 3 µg/kg and propofol 1 to 3 mg/Kg. Muscle relaxation is achieved with rocuronium 0.5 to 1,2 mg/Kg and orotracheal intubation is performed when TOF count had reached 0. Anesthesia is maintained with Desflurane and Air/Oxygen, titrated to maintain the BIS value between 40-60. Muscle relaxation is maintained with rocuronium bolus (10mg), when more than two responses are detected in TOF stimulation. The lungs are mechanically ventilated and adjusted to maintain end-tidal carbon dioxide between 35 and 45 mmHg. All patients are given a continuous infusion of polyelectrolyte solution. At the end of surgery, neuromuscular block is antagonized with standard doses of sugammadex (2mg/Kg, if TOF≥2; 4mg/Kg if TOF=0 and Post-Tetanic-Count (PTC) ≥2; 16mg/Kg, if TOF=0 and PTC<2). The endotracheal tube is removed when the TOF ratio is > 90% and BIS > 80, with the patient being conscious, with adequate spontaneous ventilation and responded to verbal commands. Perioperative analgesia is provided with intravenous paracetamol 1g (administrated after anesthetic induction), parecoxib 40mg (administrated after anesthetic induction) and local anesthetic infiltration of trocar insertion sites with ropivacaine 0.5%. When gabapentin is preoperative given, the usual doses is 600mg. Postoperative nausea and vomiting prophylaxis are assured with intravenous dexamethasone 4mg after the induction, and intravenous ondansetron 4mg at the end of the surgery.
At the postanesthesia care unit (PACU), the pain is assessed using a numeric pain rating scale at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time). The investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Patients with sedation score of at least 4 are considered sedated. The occurrence of postoperative complications is also recorded. At any time, if analgesia is inadequate, the anesthesia resident will provide intravenous bolus of morphine (0.05-0.1 mg/Kg) and stop if patient has respiratory depression (defined as respiratory rate<10 per minute or Blood Oxygen Saturation (SpO2)<90% on air) or is sedated. Droperidol 0.625mg will be given intravenously if patient had persistent nausea or had two or more episodes of retching or vomiting. Total consumption of morphine during the stay at the PACU is recorded. - Post-operative analgesia is usually provided with intravenous paracetamol 1g 8/8h and intravenous parecoxib 40mg 12/12h. If the patient still complained of pain, then rescue analgesia will be given with intravenous tramadol 100mg, maximum 8/8h. Besides that, nausea and vomiting prophylaxis are assured with intravenous ondansetron 4mg 8/8h. Total consumption of tramadol during the stay at the ward is recorded.
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin
- Keywords
- Gabapentin, laparoscopic cholecystectomy, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
One of the groups of patients was exposed to preoperative gabapentin. As the pain has a complex involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. In this case, some patients received gabapentin as a part of a multimodal analgesic technique.
| Study group | Role | What they receive |
|---|---|---|
| Group A | In the Group A, a single-dose of 600mg gabapentin was used as part of a multimodal analgesic technique. Receives: Drug: Gabapentin | |
| Group B | In the group B gabapentin was not administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores, in five different time points.
Postoperative pain will be evaluated using the Numeric Pain Rating Scale (with minimum and maximum scores varying from 0 to 10, respectively, where 0 means no pain and the value 10 represents the worst imaginable pain). Investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Higher values represent a worse outcome.
Measured: Postoperative pain is assessed at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time).
Secondary outcomes (1)
evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to total postoperative requirements of morphine and/or tramadol.
Total postoperative consumption of morphine and/or tramadol will be recorded in milligrams.
Measured: Total requirements of morphine and/or tramadol will be recorded during the first 24h of postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jul 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Rita Marques Saraiva, Centro Hospitalar do Porto
- Investigators
- Rita Saraiva, MD, Principal investigator, Centro Hospitalar do Porto, Serviço de Anestesiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583892
- Sponsor's protocol ID
- 2017 - 130 (111-DEFI/104-CES)
- Status last verified
- Aug 2019
- First submitted
- 10 May 2018
- Last updated
- 9 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Publications
Srivastava U, Kumar A, Saxena S, Mishra AR, Saraswat N, Mishra S. Effect of preoperative gabapentin on postoperative pain and tramadol consumption after minilap open cholecystectomy: a randomized double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 Apr;27(4):331-5. doi: 10.1097/EJA.0b013e328334de85.
PubMed 19935070
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03583892
- Acronym / sponsor ID
- 2017 - 130 (111-DEFI/104-CES)
- Conditions
- Pain, Postoperative
- Keywords
- Gabapentin, laparoscopic cholecystectomy, postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The multimodal analgesia involves the administration of two or more analgesic agents that exert their effects via different analgesic mechanisms, providing superior analgesia with fewer side effects. This multimodal analgesic regimen includes opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and peripheral nerve blocks. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol.
Detailed description
Postoperative pain after laparoscopic cholecystectomy is not only nociceptive but also inflammatory, neurogenic and visceral. Therefore, because of involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. The multimodal analgesic mechanisms include opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and transversus abdominis plane block. Pre-treatment with gabapentin blocks the development of hyperalgesia and tactile allodynia for up to two days. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol. In the preoperative period, consent is requested for patients who meet the inclusion criteria of the study. At this time it is verified whether gabapentin has been prescribed by the attending physician or not. If enrolled, the patient is allocated to the gabapentin group (Group A) or to the non-gabapentin group (Group B), according to his/her prescription.
All patients are monitored for electrocardiogram, pulse oximetry, noninvasive blood pressure, capnography, bispectral index (BIS®), and neuromuscular transmission with Train-of-Four (TOF®) during intraoperative period. Anesthesia is induced with intravenous fentanyl 1 to 3 µg/kg and propofol 1 to 3 mg/Kg. Muscle relaxation is achieved with rocuronium 0.5 to 1,2 mg/Kg and orotracheal intubation is performed when TOF count had reached 0. Anesthesia is maintained with Desflurane and Air/Oxygen, titrated to maintain the BIS value between 40-60. Muscle relaxation is maintained with rocuronium bolus (10mg), when more than two responses are detected in TOF stimulation. The lungs are mechanically ventilated and adjusted to maintain end-tidal carbon dioxide between 35 and 45 mmHg. All patients are given a continuous infusion of polyelectrolyte solution. At the end of surgery, neuromuscular block is antagonized with standard doses of sugammadex (2mg/Kg, if TOF≥2; 4mg/Kg if TOF=0 and Post-Tetanic-Count (PTC) ≥2; 16mg/Kg, if TOF=0 and PTC<2). The endotracheal tube is removed when the TOF ratio is > 90% and BIS > 80, with the patient being conscious, with adequate spontaneous ventilation and responded to verbal commands. Perioperative analgesia is provided with intravenous paracetamol 1g (administrated after anesthetic induction), parecoxib 40mg (administrated after anesthetic induction) and local anesthetic infiltration of trocar insertion sites with ropivacaine 0.5%. When gabapentin is preoperative given, the usual doses is 600mg. Postoperative nausea and vomiting prophylaxis are assured with intravenous dexamethasone 4mg after the induction, and intravenous ondansetron 4mg at the end of the surgery.
At the postanesthesia care unit (PACU), the pain is assessed using a numeric pain rating scale at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time). The investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Patients with sedation score of at least 4 are considered sedated. The occurrence of postoperative complications is also recorded. At any time, if analgesia is inadequate, the anesthesia resident will provide intravenous bolus of morphine (0.05-0.1 mg/Kg) and stop if patient has respiratory depression (defined as respiratory rate<10 per minute or Blood Oxygen Saturation (SpO2)<90% on air) or is sedated. Droperidol 0.625mg will be given intravenously if patient had persistent nausea or had two or more episodes of retching or vomiting. Total consumption of morphine during the stay at the PACU is recorded. - Post-operative analgesia is usually provided with intravenous paracetamol 1g 8/8h and intravenous parecoxib 40mg 12/12h. If the patient still complained of pain, then rescue analgesia will be given with intravenous tramadol 100mg, maximum 8/8h. Besides that, nausea and vomiting prophylaxis are assured with intravenous ondansetron 4mg 8/8h. Total consumption of tramadol during the stay at the ward is recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: GabapentinIn the Group A, a single-dose of 600mg gabapentin was used as part of a multimodal analgesic technique. |
| Group B | – | –In the group B gabapentin was not administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic cholecystectomy in the "Centro Hospitalar do Porto".
Key inclusion criteria (4 listed)
- Patients belonging to American Society of Anesthesiologists physical status I and II;
- Patients undergoing elective laparoscopic cholecystectomy, under general anesthesia;
- Age between 18 and 75 years;
- Patients hemodynamically stable.
Key exclusion criteria (8 listed)
- Patients with an age older than 75 years or younger than 18 years;
- Uncontrolled concomitant medical diseases (hypertension, bronchial asthma, diabetes mellitus);
- Patients with history of chronic pain conditions;
- Impaired kidney or liver function;
- History of drug or alcohol abuse;
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 |
|---|---|---|
| GabapentinOne of the groups of patients was exposed to preoperative gabapentin. As the pain has a complex involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. In this case, some patients received gabapentin as a part of a multimodal analgesic technique. | Drug | Group A |
Primary outcome
Evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores, in five different time points.
Time frame: Postoperative pain is assessed at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time).
Postoperative pain will be evaluated using the Numeric Pain Rating Scale (with minimum and maximum scores varying from 0 to 10, respectively, where 0 means no pain and the value 10 represents the worst imaginable pain). Investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Higher values represent a worse outcome.
1 secondary outcome
evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to total postoperative requirements of morphine and/or tramadol.
Time frame: Total requirements of morphine and/or tramadol will be recorded during the first 24h of postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Results publication: PubMed 19935070Srivastava U, Kumar A, Saxena S, Mishra AR, Saraswat N, Mishra S. Effect of preoperative gabapentin on postoperative pain and tramadol consumption after minilap open cholecystectomy: a randomized double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 Apr;27(4):331-5. doi: 10.1097/EJA.0b013e328334de85.
- 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.
Rita Saraiva, MD principal investigator
Centro Hospitalar do Porto, Serviço de Anestesiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Centro Hospitalar do Porto at 1 site in Portugal.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. 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 Portugal. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serviço de Anestesiologia (00351222077549, secretariado.anestesia@chporto.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores, in five different time points. (time frame: Postoperative pain is assessed at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time).). 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 NCT03583892, which also lists 1 linked publication.
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 9 Aug 2019.