Clinical Research Directory

Comparison of Analgesic Efficacy of Intrathecal Bupivacaine Versus Bupivacaine Plus Dexmedetomidine in Patients Undergoing Orthopedic Surgeries.

Sponsor: Sheikh Khalifa Bin Zayed Al Nahyan Combined Military Hospital Muzaffarabad

Summary

Clinical Trial Overview: Intrathecal Bupivacaine vs. Bupivacaine + Dexmedetomidine Primary Objective Duration of Analgesia:\*\* To compare the mean duration of postoperative pain relief between hyperbaric bupivacaine alone versus bupivacaine combined with dexmedetomidine in adults undergoing elective lower-limb orthopedic surgeries. Secondary Objectives Block Characteristics:\*\* Compare the exact onset and duration of both sensory and motor blockade. Safety Profile:\*\* Monitor and compare hemodynamic stability, focusing on side effects like hypotension (low blood pressure) and bradycardia (low heart rate). Study Design \& Framework Design:\*\* Prospective, randomized, double-blind, parallel-group controlled clinical trial. Setting:\*\* SKBZ-AK CMH, Muzaffarabad, Azad Kashmir. Sample Size:\*\* Total of 80 patients divided into two equal groups (Group B = 40, Group BD = 40) using consecutive sampling. Intervention \& Protocol Breakdown Patients will be randomly and blindly assigned to one of two distinct groups, receiving a single intrathecal (spinal) injection: * Group \| Local Anesthetic Component \| Adjuvant / Control Component \| * \--- \| --- \| --- \| * \*\*Group B (Control)\*\* \| 15 mg of 0.5% Hyperbaric Bupivacaine \| 0.5 mL Normal Saline \| * \*\*Group BD (Study)\*\* \| 15 mg of 0.5% Hyperbaric Bupivacaine \| 10 µg Dexmedetomidine \| Participant Journey \& Data Collection To maintain strict data integrity and satisfy the protocol requirements, enrolled patients will undergo a structured timeline from screening to a 24-hour postoperative monitoring phase: Screening \& Consent:\*\* Pre-Anaesthesia Clinic. Recruit patients meeting strict criteria (Aged 18-60, ASA I/II, BMI 18.5-29.9 kg/m²) and obtain informed written consent while recording baseline characteristics. Randomized Drug Delivery:\*\* Intraoperative Phase. Administer the concealed study drug at the L3-L4 or L4-L5 space. Assess the immediate onset of sensory block at the T10 dermatome and monitor vital signs every 5 to 10 minutes. 3\. \*\*Postoperative Monitoring:\*\* First 24 Hours. Track regression of sensory and motor blocks using the Modified Bromage Scale. Log the exact time to first rescue analgesia request (triggered when pain score NRS is 4 or greater) and monitor for safety endpoints. \> \*\*Operational Target:\*\* The primary hypothesis hinges on a significant extension of the time window before the first rescue analgesia is requested. International data in obstetric fields suggests a profound extension, but this trial establishes direct clinical evidence for orthopedic lower-limb procedures.

Key Details

Conditions

Interventions

Locations (1)