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Completed
NCT07827352
Comparison of Efficacy of Bupivacaine Alone vs. Bupivacaine-Tramadol in Lower Limb Surgery
Conditions: Post Operative Analgesia
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Farooq Hospital / Akhtar Saeed Medical college Rawalpindi
Location: Farooq Hospital ( Islamabad branch ) Rawalpindi Punjab Province
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07827352). StuddyBuddy aggregates publicly available trial information.