Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures

March 9, 2026 updated by: Syeda Zareen Raza, Jinnah Postgraduate Medical Centre

Efficacy of Bupivacaine Alone and Bupivacaine With Tramadol in Local Anesthesia Procedures

This study looked at two different medicines used during local anesthesia to control pain after surgery. Investigators compared bupivacaine alone with bupivacaine mixed with tramadol. Both medicines are commonly used to numb the surgical area and reduce pain.

The investigators included 100 adult patients who had minor surgeries under local anesthesia. Half received only bupivacaine, and the other half received bupivacaine combined with tramadol. After surgery, patients were asked to rate their pain at 4, 8, and 24 hours.

The results showed that patients who received bupivacaine with tramadol felt less pain, especially at 24 hours after surgery, compared to those who received bupivacaine alone.

In simple words:

Adding tramadol to bupivacaine helps reduce pain better than bupivacaine alone.

This method may help patients recover faster, feel more comfortable, and need fewer pain medicines after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Jinnah postgraduate medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing elective procedure under local anesthesia
  • Either gender.
  • Age 18-60 years.

Exclusion Criteria:

  • Procedures Under general anesthesia.
  • Diabetic patients, assessed by history and clinically and HbA1c >6.5%
  • Patients with metastatic disease, assessed by history, clinically and by imaging.
  • Patients who are I/V opioid abusers will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Use of Bupivacaine alone for treating postoperative pain
Drug: Bupivacaine
Single dose 0.5 ml/kg of 0.25% Bupivacaine at surgical site
Experimental: Use of Bupivacaine and Tramadol together for treating postoperative pain
Drug: Bupivacaine
Single dose 0.5 ml/kg of 0.25% Bupivacaine at surgical site
Drug: Tramadol
A single dose of 1 mg/kg tramadol at the surgical site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean postoperative pain score
Time Frame: Patients were monitored for 24 hours immediately following the completion of the surgical procedure
Mean postoperative pain score using the visual analog scale at 4,8 and 24 hours postoperatively. Visual Analog Scale (VAS) is a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will mark the point representing their pain intensity. Scores will be recorded at predetermined postoperative intervals.
Patients were monitored for 24 hours immediately following the completion of the surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Collaborators

Jinnah Sindh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

May 10, 2023

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.2-81/22-GENL/275/JPMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will not be shared because the dataset contains potentially identifiable clinical information collected from a relatively small study population. Participants did not provide explicit consent for public data sharing beyond the purposes of this study. In addition, the data are being used solely for predefined analyses, and there are no current plans for secondary analyses requiring external data access. Aggregate results will be published to ensure transparency while maintaining participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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