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RecruitingNCT04908579Updated Jul 7, 2026

Efficacy of Preventive Ketamine on Postoperative Pain

A Phase 4 interventional study of bupivacaine(intraperitoneally) and ketamine (intraperitoneally) and bupivacaine(intraperitoneally) and ketamine (intravenously) in Postoperative Pain, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
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Study 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 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.
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Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • - Body mass index > 35 and \< 60 kg/m2
  • Either medically free or with well controlled hypertension and/or diabetes.

Exclusion criteria

Exclusion Criteria:

  • - 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.
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    - GROUP (I): 30 patients

    Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)

  • Active comparator
    - GROUP (II): 30 patients

    Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)

  • Active comparator
    - GROUP (III) (Control): 30 patients

    Drug: bupivacaine(intraperitoneally)

Interventions

  • Drugbupivacaine(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.

  • Drugbupivacaine(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.

  • Drugbupivacaine(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.

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What researchers measure

Primary outcomes

  1. Time to first given rescue analgesia(minutes)

    Time to first given rescue analgesia(minutes)

    Time frame: 24 hours postoperatively

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04908579
Lead sponsor
Ain Shams University
Responsible party
Ibrahim Mamdouh Esmat (Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University) — Principal investigator
First posted
Jun 1, 2021
Start date
Jun 15, 2021
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 7, 2026

Study contacts

Ibrahim Mamdouh Esmat
Contact
ibrahim_mamdouh@med.asu.edu.eg
01001241928

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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