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Ketamine Irrigation Analgesia in Laparoscopic Cholecystectomy

Ketamine Irrigation Analgesia: For Controlling Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07370181
Acronym
Ketamine
Enrollment
60
Registered
2026-01-27
Start date
2026-01-30
Completion date
2026-11-03
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

ketamine, Postoperative pain, Laparoscopic Cholecystectomy

Brief 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.

Detailed description

The anesthetic technique will be standardized for all groups. Anesthesia will be induced with propofol 2 mg.kg-1, fentanyl 1 µg.kg-1 and rocuronium 0.6 mg/kg1for muscle relaxation. The size of the cuffed endotracheal tube will be selected according to the patient's age. Anesthesia and muscle relaxation will be maintained with 2% sevoflurane in a 50% oxygen/air mixture and 0.1 mg/kg rocuronium at fixed intervals. All patients will receive volume-cycled mechanical ventilation in ventilator settings that maintained normocarbia. Intra-operatively, patients will receive IV paracetamol 15 mg/kg and 10 mL/kg infusions of normal saline. Hemodynamic data (HR and MBP) will be monitored during the intraoperative period but recorded at the end of surgery before drug irrigation (T0), after extubation (T1), at postoperative care unit PACU admission (T2), then 30 min (T3), 1 hour (T4) and 2 hours (T5). Blood glucose will be measured using a point-of-care device (ACCU-CHEK©, Roche Pharmaceuticals, Basel, Switzerland) before the start of irrigation (T0), at PACU admission (T1), then after 12 hours (T2) and 24 hours (T3) to assess the effect of study drugs on the stress response. At the end of the procedure, the residual neuromuscular blockade will be reversed with standard doses of neostigmine and atropine. Patients will be extubated awake in the recovery position and transported to the Post Anesthesia Care Unit (PACU). The anesthesia time (time in minutes from induction of anesthesia till its discontinuation) and time to extubation (time in minutes from the discontinuation of anesthesia till extubation) will be recorded. After fulfilling the criteria for full recovery, patients will be transferred to the ward. Postoperative pain was assessed at rest and at movement, using a 0-10 cm VAS pain scale, where 0=no pain and 10=the worst pain imaginable. According to the degree of pain given by the patient, the classification of severity was done as follows: No pain = 0, mild pain=1-3, moderate pain= 4-6, and severe pain ≥7. The pain was treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4. The score was assessed at 0 (PACU admission), 1, 2, 4, 12, and 24 hours after surgery. The time to first request rescue analgesia and the total consumption of postoperative rescue analgesics will be recorded. Any perioperative adverse events will be treated and recorded such as hypotension, bradycardia, desaturation (SpO2% \< 92%), and postoperative vomiting.

Interventions

DRUGNormal 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)

DRUGKetamine

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The total consumption of rescue analgesics24 hoursThe 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).

Secondary

MeasureTime frameDescription
The VAS pain score24 hoursPostoperative pain was assessed, using a 0-10 cm VAS pain scale, where 0=no pain and 10=the worst pain imaginable. According to the degree of pain given by the patient, the classification of severity was done as follows: No pain = 0, mild pain=1-3, moderate pain= 4-6, and severe pain ≥7.The pain was treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4. The score was assessed at 0 (PACU admission), 1, 2, 4, 12, and 24 hours after surgery.
the time to first request for rescue analgesics24 hoursThe time to first request rescue analgesia will be recorded and treated with a bolus of pethidine 1 mg/kg when the reported VAS pain scale is ≥ 4 .

Countries

Egypt

Contacts

STUDY_DIRECTOROmar Makram Soliman, MD

Assiut University, Faculty of Medicine, Anesthesia, surgical ICU and pain management Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026