Postoperative PainPhase 4NCT04908579
Efficacy of Preventive Ketamine on Postoperative Pain
A Phase 4 study testing bupivacaine(intraperitoneally) and ketamine (intraperitoneally), bupivacaine(intraperitoneally) and ketamine (intravenously) and bupivacaine(intraperitoneally) in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- bupivacaine(intraperitoneally) and ketamine (intraperitoneally), bupivacaine(intraperitoneally) and ketamine (intravenously) and bupivacaine(intraperitoneally)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2021to 28 Oct 2026
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Body mass index > 35 and < 60 kg/m2
- Either medically free or with well controlled hypertension and/or diabetes.
Who cannot join
- - Patient's refusal to participate in the study
- BMI > 60 kg/m2.
- Age less than 21 years.
- Patients with severe systemic disease which is not life-threatening.
- Patients on antipsychotics, antidepressants and/or corticosteroids.
- Patients with history of obstructive sleep apnea.
- Allergic reaction to any of the study medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
- Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
- Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
- Conditions
- Postoperative Pain
- Being tested
- bupivacaine(intraperitoneally) and ketamine (intraperitoneally), bupivacaine(intraperitoneally) and ketamine (intravenously), bupivacaine(intraperitoneally)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine(intraperitoneally) and ketamine (intraperitoneally)Drug
- 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
- 10 ml normal saline 0.9% will be given intravenous.
bupivacaine(intraperitoneally) and ketamine (intravenously)Drug
- 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
- 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
bupivacaine(intraperitoneally)Drug
- 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
- 10 ml normal saline 0.9% will be given intravenous.
| Study group | Role | What they receive |
|---|---|---|
| - GROUP (I): 40 patients | Active comparator | Not described Receives: Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally) |
| - GROUP (II): 40 patients | Active comparator | Not described Receives: Drug: bupivacaine(intraperitoneally) and ketamine (intravenously) |
| - GROUP (III) (Control): 40 patients | Active comparator | Not described Receives: Drug: bupivacaine(intraperitoneally) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first given rescue analgesia(minutes)
Time to first given rescue analgesia(minutes)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Jun 2021
- Primary completion28 Oct 2026
- Study completion28 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908579
- Sponsor's protocol ID
- FMASU MD 87/ 2021
- Status last verified
- Oct 2026
- First submitted
- 27 May 2021
- Last updated
- 2 Nov 2026
- Results posted
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04908579
- Acronym / sponsor ID
- FMASU MD 87/ 2021
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 28 Oct 2026 (actual)
- First posted
- 1 Jun 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.
- Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
- Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| - GROUP (I): 40 patients | Active comparator | Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally) |
| - GROUP (II): 40 patients | Active comparator | Drug: bupivacaine(intraperitoneally) and ketamine (intravenously) |
| - GROUP (III) (Control): 40 patients | Active comparator | Drug: bupivacaine(intraperitoneally) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - Body mass index > 35 and < 60 kg/m2
- Either medically free or with well controlled hypertension and/or diabetes.
Key exclusion criteria (7 listed)
- - Patient's refusal to participate in the study
- BMI > 60 kg/m2.
- Age less than 21 years.
- Patients with severe systemic disease which is not life-threatening.
- Patients on antipsychotics, antidepressants and/or corticosteroids.
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 |
|---|---|---|
| bupivacaine(intraperitoneally) and ketamine (intraperitoneally)1. 40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous. | Drug | - GROUP (I): 40 patients |
| bupivacaine(intraperitoneally) and ketamine (intravenously)1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites. | Drug | - GROUP (II): 40 patients |
| bupivacaine(intraperitoneally)1. 40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 2. 10 ml normal saline 0.9% will be given intravenous. | Drug | - GROUP (III) (Control): 40 patients |
Primary outcome
Time to first given rescue analgesia(minutes)
Time frame: 24 hours postoperatively
Time to first given rescue analgesia(minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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 4 study testing bupivacaine(intraperitoneally) and ketamine (intraperitoneally), bupivacaine(intraperitoneally) and ketamine (intravenously) and bupivacaine(intraperitoneally) in people with Postoperative Pain, run by Ain Shams 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 2 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: finished, as of the sponsor's last update on 2 Nov 2026. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first given rescue analgesia(minutes) (time frame: 24 hours postoperatively). 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 2 Nov 2026.