Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy

Aswan University Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Combination Product: bupivacaine with dexamethasone; Combination Product: bupivacaine with dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06535256

Asw 917/5/24

Details and patient eligibility

About

Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

Full description

Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients scheduled for laparoscopic cholecystectomy
• Age 18-60 years
• American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria

• Patients with diabetes mellitus
• Allergy to the study drugs
• Patients on steroids
• Pregnant females
• Patients with cardiac, pulmonary, hepatic or renal disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

bupivacaine with dexamethasone

Active Comparator group

Description:

40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).

Treatment:

Combination Product: bupivacaine with dexamethasone

bupivacaine with dexmedetomidine

Active Comparator group

Description:

40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

Treatment:

Combination Product: bupivacaine with dexmedetomidine