Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy

Future University in Egypt

Status and phase: Completed; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Granisetron 1 Mg/mL Intravenous Solution; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06281418

5-24

Details and patient eligibility

About

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.

Full description

Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are scheduled to undergo elective LC.
• Adults (males and/or females) between the ages of 18-70 years old.

Exclusion criteria

• Chronic pain other than cholelithiasis.
• Patients who received analgesics or sedatives 24 h before scheduled surgery.
• Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
• Previous allergic response to granisetron.
• Pregnancy and lactation
• Patients with communication problems, cognitive dysfunction, or psychological disorders
• Daily corticosteroid use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Control arm

Placebo Comparator group

Description:

2 ml IP normal saline (0.9 % NaCl)

Treatment:

Other: Normal saline

Intervention arm

Experimental group

Description:

2ml IP granisetron (1 mg/mL)

Treatment:

Drug: Granisetron 1 Mg/mL Intravenous Solution