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

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.

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Key information

Conditions

Post Operative Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Farooq Hospital ( Islamabad branch )

Rawalpindi, Punjab Province, 45400, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Bupivacain only

Drug

15mg of 0.75% Hyperbaric Bupivacaine

bupivacain-tramadol

Drug

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Farooq Hospital / Akhtar Saeed Medical college Rawalpindi

Other

Registry information

Official study title

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

Acronym: BUP-TRA-PAIN

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Sep 18, 2026
Registry last updated: Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed