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NCT Number: NCT04908579

Efficacy of Preventive Ketamine on Postoperative Pain

* 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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Ibrahim Mamdouh Esmat

CONTACT

[email protected]

01001241928

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Time to first given rescue analgesia(minutes)

    Time frame: 24 hours postoperatively

    Time to first given rescue analgesia(minutes)

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Mamdouh Esmat

CONTACT

[email protected]

01001241928

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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