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Active, not recruiting Phase 3

Ketamine Irrigation Analgesia in Laparoscopic Cholecystectomy

NCT07370181 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2026-01-30
Last updated
2026-09-15

Condition(s) studied

Pain

Investigational drug(s) / intervention(s)

Normal salineKetamine →

Normal saline: Patients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)

Ketamine: Patients will receive 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

Study summary

Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N) or 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with age ≥18 years of ASA I-II who will be scheduled for elective laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: * History of congenital heart disease * Hypertension * Developmental delay, or * Allergy to study drugs

Primary outcome measure(s)

  • The total consumption of rescue analgesics — 24 hours
    The total consumption of postoperative rescue analgesics was recorded from the time to first request rescue analgesia to patient discharge after 24 h.
  • Systemic inflammatory response via Neutrophil-to-lymphocyte ratio (NLR) — 24 hours (One reading preoperative as a baseline and a second reading 24 hours postoperatively).
    Evaluation of the anti-inflammatory effect of intraperitoneal ketamine irrigation by measuring changes in the Neutrophil-to-Lymphocyte Ratio (NLR). NLR is calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from a standard complete blood count (CBC).

Trial sites (1)

FacilityCityRegionStatus
Assiut University Asyut Assuit
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07370181 on ClinicalTrials.gov ↗ ← All trials in Egypt