Comparison of Efficacy of Bupivacaine Alone vs. Bupivacaine-Tramadol in Lower Limb Surgery

Comparison of Mean Post-Operative Pain Score & Duration of Analgesia Following Bupivacaine Alone Versus Bupivacaine Plus Tramadol in Patients Undergoing Lower Limb Surgeries

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07827352

Acronym

BUP-TRA-PAIN

Enrollment

Registered

2026-09-18

Start date

2026-01-01

Completion date

2026-06-30

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Analgesia

Keywords

Analgesia, Bupivacaine, Tramadol, Spinal anesthesia

Brief 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. 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.

Interventions

DRUGBupivacain only

15mg of 0.75% Hyperbaric Bupivacaine

DRUGbupivacain-tramadol

15mg of 0.75% hyperbaric Bupivacaine with 15mg of Tramadol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. All Genders 2. Age between 17 to 80 years 3. ASA 1 and 2 4. Lower Limb Surgeries undergoing Spinal anesthesia

Exclusion criteria

* Patients with 1. Significant comorbid conditions falling under ASA class ≥III (Appendix). 2. BMI ≥35 Kg/m2 (calculated by diving weight in kilograms by height in meter square) 3. Diabetes (fasting blood sugar ≥110mg/dl) \& Cancer (as per history and clinical record) 4. Previous lower limb surgery in the preceding 6 months period (as per history and clinical record) 5. Patients allergic to study drugs, infection at the site of injection and neurological deficit

Design outcomes

Primary

Measure	Time frame	Description
Post operative analgesia	12 hours and 24 hours after administration of drugs	Pain score assessed using Visual Analogue Score ( 0 to 10)
Time to first rescue analgesia	Variable ( Maximum 24 Hours)	Time duration from drug administration to the first subjective request of patient for rescue analgesia.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026