Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Perioperative Pain Clinical Trial

Official title:

Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609033
• Other study ID #: 17300477
• Status: Completed
• Phase: N/A
• Start date: October 24, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Pain

Intervention

Drug:
• Bupivacaine
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
• isotonic saline
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
• Bupivacaine + morphine
instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
• Bupivacaine + morphine + ketamine
instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative level of ACTH hormone	a stress marker that increase with pain and surgery	6 hours
Secondary	VISUUEAL ANALOGE SCORE	to assess postoperative pain	24 hours