Bariatric Surgery AnalgesiaNCT07169006
The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery
A study testing Group 1 and Group 2 in people with Bariatric Surgery Analgesia, run by Ain Shams University.
Trial summary
The importance of bariatric anesthesia and analgesia research cannot be ignored as it can inform and improve the perioperative protocols for other patients with morbid obesity irrespective of the surgical procedures they are undergoing Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Analgesia
- What is being tested?
- Group 1 and Group 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with American Society of Anesthesiologists physical status ASA I to III
- both genders
- Morbid obese scheduled for bariatric surgery
Who cannot join
- patients with impaired liver or kidney disease
- patients with history of hypersensitivity to gabapentin
- patients with history of alcohol abuse, chronic pain or frequent use of analgesic
- patients with uncontrolled medical disease
About this study
The importance of bariatric anesthesia and analgesia research cannot be ignored as it can inform and improve the perioperative protocols for other patients with morbid obesity irrespective of the surgical procedures they are undergoing
Read the detailed description
Among various postoperative complications, pain is the main adverse event experienced by patients. Good control of postoperative pain is an important factor for reducing early postoperative complications such as pulmonary embolism, deep vein thrombosis, ileus, and respiratory infections, and for decreasing length of stay, lowering costs, and increasing patient satisfaction
- Conditions
- Bariatric Surgery Analgesia
- Being tested
- Group 1, Group 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Drug
Also called Gabapentin 300
Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia
Group 2Drug
Also called Placebo
will receive a placebo before standard general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia Receives: Drug: Group 1 |
| Group 2 | Placebo comparator | will receive a placebo before standard general anesthesia Receives: Drug: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS
Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assuming an effect size of 0.5 for preoperative gabapentin, a sample of 51 patients in each group would be enough to detect such effect, if true, at 0.05 alpha error and 0.80 power of the test
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169006
- Sponsor's protocol ID
- MD326/2024
- Status last verified
- Jan 2025
- First submitted
- 5 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07169006
- Acronym / sponsor ID
- MD326/2024
- Conditions
- Bariatric Surgery Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (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 importance of bariatric anesthesia and analgesia research cannot be ignored as it can inform and improve the perioperative protocols for other patients with morbid obesity irrespective of the surgical procedures they are undergoing
Detailed description
Among various postoperative complications, pain is the main adverse event experienced by patients. Good control of postoperative pain is an important factor for reducing early postoperative complications such as pulmonary embolism, deep vein thrombosis, ileus, and respiratory infections, and for decreasing length of stay, lowering costs, and increasing patient satisfaction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assuming an effect size of 0.5 for preoperative gabapentin, a sample of 51 patients in each group would be enough to detect such effect, if true, at 0.05 alpha error and 0.80 power of the test
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Group 1Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia |
| Group 2 | Placebo comparator | Drug: Group 2will receive a placebo before standard general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists physical status ASA I to III
- both genders
- Morbid obese scheduled for bariatric surgery
Key exclusion criteria (4 listed)
- patients with impaired liver or kidney disease
- patients with history of hypersensitivity to gabapentin
- patients with history of alcohol abuse, chronic pain or frequent use of analgesic
- patients with uncontrolled medical disease
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 |
|---|---|---|
| Group 1Also: Gabapentin 300Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia | Drug | Group 1 |
| Group 2Also: Placebowill receive a placebo before standard general anesthesia | Drug | Group 2 |
Primary outcome
Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS
Time frame: 24 hours postoperative
Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS
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 11 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 and Group 2 in people with Bariatric Surgery Analgesia, run by Ain Shams University.
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 4 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS (time frame: 24 hours postoperative). 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 11 Sep 2025.