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

NCT ID: NCT06535256

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-01

Brief Summary

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

Detailed 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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bupivacaine with dexamethasone

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

Group Type: ACTIVE_COMPARATOR

bupivacaine with dexamethasone

Intervention Type: COMBINATION_PRODUCT

intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).

bupivacaine with dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

bupivacaine with dexmedetomidine

Intervention Type: COMBINATION_PRODUCT

intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

Interventions

bupivacaine with dexamethasone

intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).

Intervention Type: COMBINATION_PRODUCT

bupivacaine with dexmedetomidine

intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zaher Zaki Zaher

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zaher

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Asw 917/5/24

Identifier Type: -

Identifier Source: org_study_id