Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole

Pain, Postoperative Clinical Trial

Official title:

A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05264805
• Other study ID #: N0333
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2022
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Hamdard University
• Contact: Dr. Nida Shahid, MBBS, FCPS
• Phone: +923332358698
• Email: nida-shahid2011[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Description:

The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 166
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients of both the gender of age >18 years and <45years

2. Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

3. Patients with A.S.A grade I and II.

Exclusion Criteria:

1. Patients with known allergic reactions to local anesthetics.

2. Patients converted to open procedure.

3. Patients developing intra-operative complications.

4. Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.

5. Patients with obesity and chronic illness.

6. Patients with history of opioids, steroids, NSAIDs and alcohol use.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 0.25% Bupivacaine
20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post laparoscopic port site pain assessment	Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.	Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour