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COMPLETED
NCT07827352
PHASE4

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

Sponsor: Farooq Hospital / Akhtar Saeed Medical college Rawalpindi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01-01

Completion Date

2026-06-30

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Bupivacain only

15mg of 0.75% Hyperbaric Bupivacaine

DRUG

bupivacain-tramadol

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

Locations (1)

Farooq Hospital ( Islamabad branch )

Rawalpindi, Punjab Province, Pakistan