Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Perioperative Pain
• Interventions: Drug: Bupivacaine + morphine + ketamine; Drug: isotonic saline; Drug: Bupivacaine + morphine; Drug: Bupivacaine

• Registration Number: NCT04609033
• Lead Sponsor: Assiut University

Brief Summary

Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

Detailed Description

The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-10-23
• Study Start: 2020-10-24
• Study First Posted: 2020-10-30
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients scheduled for Laparoscopic cholecystectomy.
• Age spectrum of 18 - 55 years
• ASA I, II
• Have no comorbid chronic medical diseases

Exclusion Criteria

• Patients with co morbid medical diseases
• Age outside the specified range
• Acute inflammation of the gall bladder
• Critically ill patient
• Emergency operations
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine + morphine + ketamine	Bupivacaine + morphine + ketamine	-
isotonic saline	isotonic saline	-
bupivacaine + morphine	Bupivacaine + morphine	-
bupivacaine group	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
postoperative level of ACTH hormone	6 hours	a stress marker that increase with pain and surgery

Secondary Outcome Measures

Name	Time	Method
VISUUEAL ANALOGE SCORE	24 hours	to assess postoperative pain

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt