Post Operative Pain, AcutePhase 3NCT07469826
Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures
A Phase 3 study testing Tramadol and Bupivacaine in people with Post Operative Pain, Acute, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Tramadol and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2022to 10 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients undergoing elective procedure under local anesthesia
- Either gender.
- Age 18-60 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Tramadol, Bupivacaine
- Keywords
- Bupivacaine, Tramadol, Post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
A single dose of 1 mg/kg tramadol at the surgical site
BupivacaineDrug
Single dose 0.5 ml/kg of 0.25% Bupivacaine at surgical site
| Study group | Role | What they receive |
|---|---|---|
| Use of Bupivacaine alone for treating postoperative pain | Active comparator | Not described Receives: Drug: Bupivacaine |
| Use of Bupivacaine and Tramadol together for treating postoperative pain | Experimental | Not described Receives: Drug: Tramadol; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients were monitored for 24 hours immediately following the completion of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Oct 2022
- Primary completion10 Apr 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Collaborators
- Jinnah Sindh Medical University
- Responsible party
- Principal investigator, Syeda Zareen Raza, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469826
- Sponsor's protocol ID
- F.2-81/22-GENL/275/JPMC
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
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.
PubMed 18940114Passavanti 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.
PubMed 32660546Kelley 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.
PubMed 26213198Obsa 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
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.
PubMed 26827847Jenkins 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.
PubMed 32076833Gan 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.
PubMed 29026331Kuusniemi 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.
PubMed 26893579Labrum 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.
PubMed 28867907
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bupivacaine Alone and Bupivacaine With Tramadol in Local Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT07469826
- Acronym / sponsor ID
- F.2-81/22-GENL/275/JPMC
- Conditions
- Post Operative Pain, Acute
- Keywords
- Bupivacaine, Tramadol, Post operative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Collaborators
- Jinnah Sindh Medical University
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients undergoing elective procedure under local anesthesia
- Either gender.
- Age 18-60 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolA single dose of 1 mg/kg tramadol at the surgical site | Drug | Use of Bupivacaine and Tramadol together for treating postoperative pain |
| BupivacaineSingle dose 0.5 ml/kg of 0.25% Bupivacaine at surgical site | Drug | Use of Bupivacaine alone for treating postoperative pain, Use of Bupivacaine and Tramadol together for treating postoperative pain |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- BackgroundMalik 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: PubMed 18940114Khan 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.
- Background: PubMed 32660546Passavanti 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.
- Background: PubMed 26213198Kelley 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.
- BackgroundObsa 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: PubMed 26827847Chou 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.
- Background: PubMed 32076833Jenkins 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.
- Background: PubMed 29026331Gan 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.
- Background: PubMed 26893579Kuusniemi 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.
- Background: PubMed 28867907Labrum 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol and Bupivacaine in people with Post Operative Pain, Acute, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean postoperative pain score (time frame: Patients were monitored for 24 hours immediately following the completion of the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469826, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.