Gynecologic DiseaseNCT04708353
Oral Pregabalin Premedication for Postoperative Pain Relief
A study testing Group pregabalin 150 and Group pregabalin 300 in people with Gynecologic Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Group pregabalin 150 and Group pregabalin 300
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to Nov 2021
- Phase
- Interventional
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Physical status: ASA I-II
- BMI ≥ 20kg/m2 \& ≤ 35kg/m2,
- Written informed consent from the patient.
Who cannot join
- Patients with known history of allergy to study drugs,
- Patients on ACE inhibitors, anticonvulsant therapy or any drug interacting with pregabalin,
- Patients on chronic alcohol, opioid, tranquilizer or sedative use,
- Patient with renal impairment or heart failure,
- Pregnant females, Psychological, mental disorders or depression,
- Patients receiving anticoagulants therapy or suspected coagulopathy,
- Patients already on pregbalin or gabapentin therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine, Zagazig university
Zagazig, Elsharqya, 44519
Howaida A Kamal, MD, 01225096755 ext. 002, k.howaida@yahoo.com
About this study
Official title: Effect of Two Different Doses of Oral Pregabalin Premedication for Postoperative Pain Relief After Gynecological Surgeries
Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression.
Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial.
In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
Read the detailed description
Postoperative pain, nausea and vomiting continue to be one of the most common and unpleasant complications after surgery. The traditional pain treatment with opioids alone is not adequate any more. To optimize pain treatment and postoperative outcome, new analgesics and new combination of already existing analgesics are searched for.
Pain after gynecological surgery usually severe. Uncontrolled acute post-operative pain is associated with dissatisfaction, post-operative complications and considered as a strong risk factor for development of chronic pain. An enhanced recovery pathway for gynecological surgery must include a strategy to effectively control post-operative pain and allow attainment of other Enhanced Recovery After Surgery (ERAS) targets such as early mobilization and return to oral diet whilst reducing the need for opiates.
Beyond increasing the risk of developing opioid use disorder, perioperative opioid consumption may produce undesirable side effects such as nausea, vomiting, constipation, ileus, pruritus, altered mental status, urinary retention, respiratory complications and increased length of hospital stay. While many of these side effects are frustrating to patient in the immediate postoperative period, the most dangerous effects are those that affect the respiratory system such as opioid-induced respiratory depression (ORD) which consider as a significant cause of brain damage and death in the postoperative period.
Opioid reduction strategies prove useful for decreasing total opioid dose and, in turn, their associated adverse effects. Such strategies may include adjuvant non opioid analgesics such as α-2 agonists, gabapentinoids and N-methyl-D-aspartate receptor agonists as well as local, regional or neuraxial anesthesia and modification of surgical technique where possible for operative patients.
Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid. It is a α2-δ ligand that has analgesic, anticonvulsant, anxiolytic and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters including glutamate, noradrenaline, serotonin, dopamine and substance P.
Pregabalin could reduce the hyperexcitability of dorsal horn neurons induced by tissue damage; therefore it may be useful in the postsurgical pain prevention.
In 2015, a meta-analysis published in British Medical Journal (BMJ) suggested that pregabalin could improve postoperative analgesia and opioid-related adverse effects namely, vomiting and visual disturbances after surgery. However, the use of the pregabalin for acute postoperative pain is still under trial though widely reported.
- Conditions
- Gynecologic Disease
- Being tested
- placebo capsule (vitamin c), Group pregabalin 150, Group pregabalin 300
- Keywords
- Oral Pregabalin, Postoperative Pain Relief, Gynecological Surgeries
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo capsule (vitamin c)Drug
the patient will receive one placebo capsule (vitamin c) once one hour before the operation
Group pregabalin 150Drug
Also called p150
the patient will receive one capsule of pregabalin 150 mg once one hour before the operation
Group pregabalin 300Drug
Also called p300
the patient will receive one capsule of pregabalin 300 mg once one hour before the operation
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | the patient will receive one placebo capsule (vitamin c) once one hour before the operation. Receives: Drug: placebo capsule (vitamin c) |
| Group Pregabalin 150 | Active comparator | the patient will receive one capsule of pregabalin 150 mg once one hour before the operation Receives: Drug: Group pregabalin 150 |
| Group Pregabalin 300 | Active comparator | the patient will receive one capsule of pregabalin 300 mg once one hour before the operation Receives: Drug: Group pregabalin 300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Postoperative pain
will be assessed by visual analogue scale (VAS), On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Measured: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively
Secondary outcomes (2)
The level of sedation
using the modified Ramsay Sedation Score:
- Patient is anxious and agitated or restless, or both.
- Patient is cooperative, oriented and tranquil.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
- Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response.
Measured: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively
Total amount of rescue analgesic
Total amount of rescue analgesic requirement by the patient
Measured: in the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start20 Aug 2020
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be allocated randomly using computer generated randomization table into three equal groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asmaa Mohammed Galal El-Deen, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708353
- Sponsor's protocol ID
- 19-11-2020
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87.
PubMed 16503325Dahl JB, Mathiesen O, Moiniche S. 'Protective premedication': an option with gabapentin and related drugs? A review of gabapentin and pregabalin in in the treatment of post-operative pain. Acta Anaesthesiol Scand. 2004 Oct;48(9):1130-6. doi: 10.1111/j.1399-6576.2004.00484.x.
PubMed 15352959Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.
PubMed 25209095Balaban F, Yagar S, Ozgok A, Koc M, Gullapoglu H. A randomized, placebo-controlled study of pregabalin for postoperative pain intensity after laparoscopic cholecystectomy. J Clin Anesth. 2012 May;24(3):175-8. doi: 10.1016/j.jclinane.2011.06.027. Epub 2012 Mar 28.
PubMed 22459341
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Doses of Oral Pregabalin Premedication for Postoperative Pain Relief After Gynecological Surgeries
- ClinicalTrials.gov ID
- NCT04708353
- Acronym / sponsor ID
- 19-11-2020
- Conditions
- Gynecologic Disease
- Keywords
- Oral Pregabalin, Postoperative Pain Relief, Gynecological Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Jan 2021 (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.
Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression.
Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial.
In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
Detailed description
Postoperative pain, nausea and vomiting continue to be one of the most common and unpleasant complications after surgery. The traditional pain treatment with opioids alone is not adequate any more. To optimize pain treatment and postoperative outcome, new analgesics and new combination of already existing analgesics are searched for.
Pain after gynecological surgery usually severe. Uncontrolled acute post-operative pain is associated with dissatisfaction, post-operative complications and considered as a strong risk factor for development of chronic pain. An enhanced recovery pathway for gynecological surgery must include a strategy to effectively control post-operative pain and allow attainment of other Enhanced Recovery After Surgery (ERAS) targets such as early mobilization and return to oral diet whilst reducing the need for opiates.
Beyond increasing the risk of developing opioid use disorder, perioperative opioid consumption may produce undesirable side effects such as nausea, vomiting, constipation, ileus, pruritus, altered mental status, urinary retention, respiratory complications and increased length of hospital stay. While many of these side effects are frustrating to patient in the immediate postoperative period, the most dangerous effects are those that affect the respiratory system such as opioid-induced respiratory depression (ORD) which consider as a significant cause of brain damage and death in the postoperative period.
Opioid reduction strategies prove useful for decreasing total opioid dose and, in turn, their associated adverse effects. Such strategies may include adjuvant non opioid analgesics such as α-2 agonists, gabapentinoids and N-methyl-D-aspartate receptor agonists as well as local, regional or neuraxial anesthesia and modification of surgical technique where possible for operative patients.
Pregabalin is a new synthetic molecule and a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid. It is a α2-δ ligand that has analgesic, anticonvulsant, anxiolytic and sleep-modulating activities. Pregabalin binds potently to the α2-δ subunit of calcium channels, resulting in a reduction in the release of several neurotransmitters including glutamate, noradrenaline, serotonin, dopamine and substance P.
Pregabalin could reduce the hyperexcitability of dorsal horn neurons induced by tissue damage; therefore it may be useful in the postsurgical pain prevention.
In 2015, a meta-analysis published in British Medical Journal (BMJ) suggested that pregabalin could improve postoperative analgesia and opioid-related adverse effects namely, vomiting and visual disturbances after surgery. However, the use of the pregabalin for acute postoperative pain is still under trial though widely reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be allocated randomly using computer generated randomization table into three equal groups
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: placebo capsule (vitamin c)the patient will receive one placebo capsule (vitamin c) once one hour before the operation. |
| Group Pregabalin 150 | Active comparator | Drug: Group pregabalin 150the patient will receive one capsule of pregabalin 150 mg once one hour before the operation |
| Group Pregabalin 300 | Active comparator | Drug: Group pregabalin 300the patient will receive one capsule of pregabalin 300 mg once one hour before the operation |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physical status: ASA I-II
- BMI ≥ 20kg/m2 \& ≤ 35kg/m2,
- Written informed consent from the patient.
Key exclusion criteria (7 listed)
- Patients with known history of allergy to study drugs,
- Patients on ACE inhibitors, anticonvulsant therapy or any drug interacting with pregabalin,
- Patients on chronic alcohol, opioid, tranquilizer or sedative use,
- Patient with renal impairment or heart failure,
- Pregnant females, Psychological, mental disorders or depression,
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 |
|---|---|---|
| placebo capsule (vitamin c)the patient will receive one placebo capsule (vitamin c) once one hour before the operation | Drug | control group |
| Group pregabalin 150Also: p150the patient will receive one capsule of pregabalin 150 mg once one hour before the operation | Drug | Group Pregabalin 150 |
| Group pregabalin 300Also: p300the patient will receive one capsule of pregabalin 300 mg once one hour before the operation | Drug | Group Pregabalin 300 |
Primary outcome
changes in Postoperative pain
Time frame: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively
will be assessed by visual analogue scale (VAS), On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
2 secondary outcomes
The level of sedation
Time frame: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively
Total amount of rescue analgesic
Time frame: in the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 16503325Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87.
- Background: PubMed 15352959Dahl JB, Mathiesen O, Moiniche S. 'Protective premedication': an option with gabapentin and related drugs? A review of gabapentin and pregabalin in in the treatment of post-operative pain. Acta Anaesthesiol Scand. 2004 Oct;48(9):1130-6. doi: 10.1111/j.1399-6576.2004.00484.x.
- Background: PubMed 25209095Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.
- Background: PubMed 22459341Balaban F, Yagar S, Ozgok A, Koc M, Gullapoglu H. A randomized, placebo-controlled study of pregabalin for postoperative pain intensity after laparoscopic cholecystectomy. J Clin Anesth. 2012 May;24(3):175-8. doi: 10.1016/j.jclinane.2011.06.027. Epub 2012 Mar 28.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group pregabalin 150 and Group pregabalin 300 in people with Gynecologic Disease, run by Zagazig University at 1 site in Egypt.
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 3 inclusion and 7 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 5 Sep 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 Egypt. 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.
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 Asmaa M Galal, MD (01271550089 ext. 002, asmaa_galal79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Postoperative pain (time frame: at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively). 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 NCT04708353, which also lists 4 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 5 Sep 2021.