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

NCT ID: NCT05264805

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2022-09-30

Brief Summary

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

Detailed Description

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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine group

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

Group Type EXPERIMENTAL

0.25% Bupivacaine

Intervention Type DRUG

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

Placebo group

No drug infiltration at laparoscopic port site

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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0.25% Bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Bupivacain

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamdard University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nida Shahid

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dr. Nida Shahid, MBBS, FCPS

Role: CONTACT

+923332358698

Other Identifiers

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N0333

Identifier Type: -

Identifier Source: org_study_id

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