Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures

NCT07469826 | Completed Phase 3

• 1 other identifier: F.2-81/22-GENL/275/JPMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain, Acute

Keywords

Bupivacaine; Tramadol; Post operative pain

Outcome Measures

Primary Outcomes (1)

• Mean postoperative pain score

  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

Study Arms (2)

Use of Bupivacaine alone for treating postoperative pain

ACTIVE COMPARATOR

Drug: Bupivacaine

Use of Bupivacaine and Tramadol together for treating postoperative pain

EXPERIMENTAL

Drug: Tramadol; Drug: Bupivacaine

Interventions

Tramadol DRUG

A single dose of 1 mg/kg tramadol at the surgical site

Use of Bupivacaine and Tramadol together for treating postoperative pain

Bupivacaine DRUG

Single dose 0.5 ml/kg of 0.25% Bupivacaine at surgical site

Use of Bupivacaine alone for treating postoperative pain; Use of Bupivacaine and Tramadol together for treating postoperative pain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead
• Jinnah Sindh Medical University: collaborator

Study Sites (1)

Jinnah postgraduate medical university

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (10)

• Malik AI, Sheikh IA, Qasmi SA, Adnan A. Comparison of tramadol with bupivacaine as local anaesthetic in postoperative pain control. Journal of Surgery Pakistan (International). 2011 Jan;16(1):10-3.

  BACKGROUND

• Khan S, Memon MI. Comparison of caudal bupivacaine and bupivacaine-tramadol for postoperative analgesia in children with hypospadias repair. J Coll Physicians Surg Pak. 2008 Oct;18(10):601-4. doi: 10.2008/JCPSP.601604.

  PMID: 18940114 BACKGROUND

• Passavanti MB, Piccinno G, Alfieri A, Di Franco S, Sansone P, Mangoni G, Pota V, Aurilio C, Pace MC, Fiore M. Local infiltration of tramadol as an effective strategy to reduce post-operative pain: a systematic review protocol and meta-analysis. Syst Rev. 2020 Jul 13;9(1):157. doi: 10.1186/s13643-020-01419-1.

  PMID: 32660546 BACKGROUND

• Kelley BP, Shauver MJ, Chung KC. Management of Acute Postoperative Pain in Hand Surgery: A Systematic Review. J Hand Surg Am. 2015 Aug;40(8):1610-9, 1619.e1. doi: 10.1016/j.jhsa.2015.05.024.

  PMID: 26213198 BACKGROUND

• Obsa MS, Andebirku AA, Gemechu AD, Haile KE. Effectiveness of tramadol with bupivacaine versus bupivacaine alone on postoperative analgesia at Wolaita Sodo, southern Ethiopia: Observational Cohort Study. 2021

  BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Jenkins NW, Parrish JM, Mayo BC, Hrynewycz NM, Brundage TS, Mogilevsky FA, Yoo JS, Singh K. The identification of risk factors for increased postoperative pain following minimally invasive transforaminal lumbar interbody fusion. Eur Spine J. 2020 Jun;29(6):1304-1310. doi: 10.1007/s00586-020-06344-4. Epub 2020 Feb 19.

  PMID: 32076833 BACKGROUND

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Kuusniemi K, Poyhia R. Present-day challenges and future solutions in postoperative pain management: results from PainForum 2014. J Pain Res. 2016 Feb 3;9:25-36. doi: 10.2147/JPR.S92502. eCollection 2016.

  PMID: 26893579 BACKGROUND

• Labrum JT 4th, Ilyas AM. Preemptive Analgesia in Thumb Basal Joint Arthroplasty: Immediate Postoperative Pain with Preincision versus Postincision Local Anesthesia. J Hand Microsurg. 2017 Aug;9(2):80-83. doi: 10.1055/s-0037-1603734. Epub 2017 Jun 5.

  PMID: 28867907 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: March 13, 2026
• Study Start: October 10, 2022
• Primary Completion: April 10, 2023
• Study Completion: May 10, 2023
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)