Post Operative PainPhase 3NCT05921604
Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
A Phase 3 study testing Baclofen 10mg and Gabapentin in people with Post Operative Pain, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Baclofen 10mg and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2023to Oct 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Age between 18-60 years old.
- Both male and female patients will be included.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
- Patients fit for anesthesia and surgery.
Who cannot join
- Patients with BMI >55 kg/m2.
- Patients with previous procedures for the treatment of obesity.
- Pregnant females and lactating women.
- Patients with psychological or psychiatric disease
- Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
- Patients who experienced vomiting within 24 hours before surgery.
- Patients with history of alcohol or drug abuse.
- Patients with hypersensitivity or contraindications to any of the drugs used in this study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt
Tanta, Gharbia Governorate, 31111
About this study
Official title: Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve
The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
- Conditions
- Post Operative Pain
- Being tested
- Baclofen 10mg, Gabapentin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 10mgDrug
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
GabapentinDrug
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (baclofen) | Experimental | which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia. Receives: Drug: Baclofen 10mg |
| Group 2 (gabapentin) | Experimental | which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) score
During the first 48-h postoperative study period, patients were asked to rate their intensity of pain using visual analog scale (VAS) scores. the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: The first 48 hours after surgery.
Secondary outcomes (1)
sedation score
Postoperative sedation scores will be evaluated using the following scale: 0 = awake, 1 = mild sedation, 2 = sleepy but arousable, and 3 = very sleepy.
Measured: The first 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start30 Jun 2023
- Primary completion28 Aug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Tanta 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Moussa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921604
- Sponsor's protocol ID
- 35648
- Status last verified
- Nov 2024
- First submitted
- 6 Jun 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve
- ClinicalTrials.gov ID
- NCT05921604
- Acronym / sponsor ID
- 35648
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Jun 2023 (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 aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
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 1 (baclofen) | Experimental | Drug: Baclofen 10mgwhich will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia. |
| Group 2 (gabapentin) | Experimental | Drug: Gabapentinwhich include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Age between 18-60 years old.
- Both male and female patients will be included.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
- Patients fit for anesthesia and surgery.
Key exclusion criteria (8 listed)
- Patients with BMI >55 kg/m2.
- Patients with previous procedures for the treatment of obesity.
- Pregnant females and lactating women.
- Patients with psychological or psychiatric disease
- Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
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 |
|---|---|---|
| Baclofen 10mgwhich will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia. | Drug | Group 1 (baclofen) |
| Gabapentinwhich include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia. | Drug | Group 2 (gabapentin) |
Primary outcome
visual analog scale (VAS) score
Time frame: The first 48 hours after surgery.
During the first 48-h postoperative study period, patients were asked to rate their intensity of pain using visual analog scale (VAS) scores. the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
1 secondary outcome
sedation score
Time frame: The first 48 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baclofen 10mg and Gabapentin in people with Post Operative Pain, run by Tanta 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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
visual analog scale (VAS) score (time frame: The first 48 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2025.