Post Operative AnalgesiaPhase 4BUP-TRA-PAINNCT07827352
Comparison of Efficacy of Bupivacaine Alone vs. Bupivacaine-Tramadol in Lower Limb Surgery
A Phase 4 study testing Bupivacain only and bupivacain-tramadol in people with Post Operative Analgesia, run by Farooq Hospital / Akhtar Saeed Medical college Rawalpindi at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of bupivacaine alone versus bupivacaine combined with tramadol for postoperative analgesia in patients undergoing lower limb surgeries under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Bupivacain only and bupivacain-tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Genders
- Age between 17 to 80 years
- ASA 1 and 2
- Lower Limb Surgeries undergoing Spinal anesthesia
Who cannot join
- Patients with
- Significant comorbid conditions falling under ASA class ≥III (Appendix).
- BMI ≥35 Kg/m2 (calculated by diving weight in kilograms by height in meter square)
- Diabetes (fasting blood sugar ≥110mg/dl) \& Cancer (as per history and clinical record)
- Previous lower limb surgery in the preceding 6 months period (as per history and clinical record)
- Patients allergic to study drugs, infection at the site of injection and neurological deficit
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Farooq Hospital ( Islamabad branch )
Rawalpindi, Punjab Province, 45400
About this study
Official title: Comparison of Mean Post-Operative Pain Score & Duration of Analgesia Following Bupivacaine Alone Versus Bupivacaine Plus Tramadol in Patients Undergoing Lower Limb Surgeries
This randomized controlled trial aims to compare the effectiveness of bupivacaine alone versus bupivacaine combined with tramadol for postoperative analgesia in patients undergoing lower limb surgeries under spinal anesthesia. A total of 60 patients, aged 18-70 years and classified as ASA I or II, were included and randomly divided into two groups of 30 patients each. The bupivacaine group received 15 mg of 0.75% hyperbaric bupivacaine, while the combination group received 15 mg bupivacaine with 15 mg tramadol. Postoperative pain was assessed using the Visual Analogue Scale (VAS), and the duration of analgesia was recorded as the time from administration of the drug until the patient developed a VAS score of ≥3, indicating the need for rescue analgesia. The findings suggested that adding tramadol to bupivacaine provided better and longer-lasting postoperative pain relief compared with bupivacaine alone.
- Conditions
- Post Operative Analgesia
- Being tested
- Bupivacain only, bupivacain-tramadol
- Keywords
- Analgesia, Bupivacaine, Tramadol, Spinal anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain onlyDrug
15mg of 0.75% Hyperbaric Bupivacaine
bupivacain-tramadolDrug
15mg of 0.75% hyperbaric Bupivacaine with 15mg of Tramadol
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | 15mg of 0.75% Hyperbaric Bupivacaine Receives: Drug: Bupivacain only |
| Bupivacaine plus Tramadol | Active comparator | 15mg of 0.75% Hyperbaric Bupivacaine plus 15mg Tramadol Receives: Drug: bupivacain-tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative analgesia
Pain score assessed using Visual Analogue Score ( 0 to 10)
Measured: 12 hours and 24 hours after administration of drugs
Time to first rescue analgesia
Time duration from drug administration to the first subjective request of patient for rescue analgesia.
Measured: Variable ( Maximum 24 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farooq Hospital / Akhtar Saeed Medical college Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Affifa Saleem, Farooq Hospital / Akhtar Saeed Medical college Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827352
- Sponsor's protocol ID
- IEC2403
- Other IDs
- CPSP/REU/ANS-2023-406-3162
- Acronym
- BUP-TRA-PAIN
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Post-Operative Pain Score & Duration of Analgesia Following Bupivacaine Alone Versus Bupivacaine Plus Tramadol in Patients Undergoing Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT07827352
- Acronym / sponsor ID
- BUP-TRA-PAIN / IEC2403
- Conditions
- Post Operative Analgesia
- Keywords
- Analgesia, Bupivacaine, Tramadol, Spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Farooq Hospital / Akhtar Saeed Medical college RawalpindiUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Sep 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 randomized controlled trial aims to compare the effectiveness of bupivacaine alone versus bupivacaine combined with tramadol for postoperative analgesia in patients undergoing lower limb surgeries under spinal anesthesia. A total of 60 patients, aged 18-70 years and classified as ASA I or II, were included and randomly divided into two groups of 30 patients each. The bupivacaine group received 15 mg of 0.75% hyperbaric bupivacaine, while the combination group received 15 mg bupivacaine with 15 mg tramadol. Postoperative pain was assessed using the Visual Analogue Scale (VAS), and the duration of analgesia was recorded as the time from administration of the drug until the patient developed a VAS score of ≥3, indicating the need for rescue analgesia. The findings suggested that adding tramadol to bupivacaine provided better and longer-lasting postoperative pain relief compared with bupivacaine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacain only15mg of 0.75% Hyperbaric Bupivacaine |
| Bupivacaine plus Tramadol | Active comparator | Drug: bupivacain-tramadol15mg of 0.75% Hyperbaric Bupivacaine plus 15mg Tramadol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All Genders
- Age between 17 to 80 years
- ASA 1 and 2
- Lower Limb Surgeries undergoing Spinal anesthesia
Key exclusion criteria (6 listed)
- Patients with
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 |
|---|---|---|
| Bupivacain only15mg of 0.75% Hyperbaric Bupivacaine | Drug | Bupivacaine |
| bupivacain-tramadol15mg of 0.75% hyperbaric Bupivacaine with 15mg of Tramadol | Drug | Bupivacaine plus Tramadol |
Primary outcome
Post operative analgesia
Time frame: 12 hours and 24 hours after administration of drugs
Pain score assessed using Visual Analogue Score ( 0 to 10)
Time to first rescue analgesia
Time frame: Variable ( Maximum 24 Hours)
Time duration from drug administration to the first subjective request of patient for rescue analgesia.
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 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 4 study testing Bupivacain only and bupivacain-tramadol in people with Post Operative Analgesia, run by Farooq Hospital / Akhtar Saeed Medical college Rawalpindi 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 4 inclusion and 6 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 18 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Post operative analgesia (time frame: 12 hours and 24 hours after administration of drugs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.