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

NCT05264805 | Unknown Phase 3

• 1 other identifier: N0333
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

#Post operative pain; #laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bupivacaine group

EXPERIMENTAL

Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site

Drug: 0.25% Bupivacaine

Placebo group

NO INTERVENTION

No drug infiltration at laparoscopic port site

Interventions

0.25% Bupivacaine DRUG

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

Also known as: Bupivacain

Bupivacaine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both the gender of age \>18 years and \<45years
• Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
• Patients with A.S.A grade I and II.

You may not qualify if:

• Patients with known allergic reactions to local anesthetics.
• Patients converted to open procedure.
• Patients developing intra-operative complications.
• Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
• Patients with obesity and chronic illness.
• Patients with history of opioids, steroids, NSAIDs and alcohol use.

Sponsors & Collaborators

• Hamdard University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Dr. Nida Shahid, MBBS, FCPS

CONTACT

+923332358698; nida-shahid2011@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group A: Study group: Patient receiving intervention i.e 20ml of 0.25% buvivacaine infiltration at laparoscopic port site. Group B: Control group: no intervention

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 3, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03