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

NCT07827352 | Completed Phase 4

• 2 other identifiers: IEC2403CPSP/REU/ANS-2023-406-3162
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Analgesia

Keywords

Analgesia; Bupivacaine; Tramadol; Spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• Post operative analgesia

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

  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.

  Variable ( Maximum 24 Hours)

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

15mg of 0.75% Hyperbaric Bupivacaine

Drug: Bupivacain only

Bupivacaine plus Tramadol

ACTIVE COMPARATOR

15mg of 0.75% Hyperbaric Bupivacaine plus 15mg Tramadol

Drug: bupivacain-tramadol

Interventions

Bupivacain only DRUG

15mg of 0.75% Hyperbaric Bupivacaine

Bupivacaine

bupivacain-tramadol DRUG

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

Bupivacaine plus Tramadol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farooq Hospital / Akhtar Saeed Medical college Rawalpindi: lead

Study Sites (1)

Farooq Hospital ( Islamabad branch )

Rawalpindi, Punjab Province, 45400, Pakistan

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate trainee

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: January 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

PA (1)