Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Assiut University

Status: Completed

Conditions: Perioperative Pain

Treatments: Drug: Bupivacaine + morphine + ketamine; Drug: isotonic saline; Drug: Bupivacaine + morphine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04609033

17300477

Details and patient eligibility

About

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

Full 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

Enrollment: 110 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 4 patient groups, including a placebo group

bupivacaine group

Active Comparator group

Treatment:

Drug: Bupivacaine

bupivacaine + morphine

Active Comparator group

Treatment:

Drug: Bupivacaine + morphine

bupivacaine + morphine + ketamine

Active Comparator group

Treatment:

Drug: Bupivacaine + morphine + ketamine

isotonic saline

Placebo Comparator group

Treatment:

Drug: isotonic saline