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

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.

Timeline

Start

2026-08-01

Primary completion

2026-10-31

Completion

2026-10-31

Publications

• Background Mohamed T, Susheela I, Balakrishnan BP, Kaniyil S. Dexmedetomidine as Adjuvant to Lower Doses of Intrathecal Bupivacaine for Lower Limb Orthopedic Surgeries. Anesth Essays Res. 2017 Jul-Sep;11(3):681-685. doi: 10.4103/aer.AER_243_16.
• Background Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, Saikia D. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022 Dec 12;14(12):e32425. doi: 10.7759/cureus.32425. eCollection 2022 Dec.
• Background Farmawy MSE, Mowafy SMS, Wahdan RA. Epidural nalbuphine versus dexmedetomidine as adjuvants to bupivacaine in lower limb orthopedic surgeries for postoperative analgesia: a randomized controlled trial. BMC Anesthesiol. 2023 Dec 6;23(1):401. doi: 10.1186/s12871-023-02348-x.
• Background Giaccari LG, Coppolino F, Aurilio C, Pace MC, Passavanti MB, Pota V, Sansone P. Is intrathecal bupivacaine plus dexmedetomidine superior to bupivacaine in spinal anesthesia for a cesarean section? A systematic review and meta-analysis. Eur Rev Med Pharmacol Sci. 2024 Aug;28(15):4067-4079. doi: 10.26355/eurrev_202408_36638.
• Background Jin Z, Xia F, Lin T, Cai Y, Chen H, Wang Y. Dexmedetomidine may decrease the bupivacaine toxicity to heart. Open Med (Wars). 2021 Jul 15;16(1):1070-1075. doi: 10.1515/med-2021-0311. eCollection 2021.
• Background Khan MK, Hafeez A, Feroze F, Tahir AA, Abbasi S, Faheem MSB, Farooq S. Effect Of Perineural Administration Of Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone In Ultrasound Guided Supraclavicular Block For Upper Extremity Orthopaedic Operations. J Ayub Med Coll Abbottabad. 2023 Jul-Sep;35(3):384-389. doi: 10.55519/JAMC-03-12044.
• Background Alam SS, Abbas N, Asgher A, Rafique M; Anees-ur-Rehman; Abid K. Effectiveness Of Intrathecal Dexmedetomidine In Combination With Hyperbaric Bupivacaine For Lower Abdominal Surgeries And Its Postoperative Analgesic Characteristic. J Ayub Med Coll Abbottabad. 2022 Oct-Dec;34(Suppl 1)(4):S936-S939. doi: 10.55519/JAMC-04-S4-10179.
• Background Olawin AM, Das JM. Spinal Anesthesia. 2022 Jun 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537299/

Drugs

Indications

No indication recorded.