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

Farooq Hospital / Akhtar Saeed Medical college Rawalpindi60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Post Operative Analgesia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Post operative analgesia

Pain score assessed using Visual Analogue Score ( 0 to 10)

Time frame: 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.

Time frame: Variable ( Maximum 24 Hours)