Effect of Nalbhupine Versus Fentanyl in Spinal Anesthesia

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Spinal Anesthesia: Use of Hyperbaric Bupivacaine 0.5 percent with two adjuvant as comparator agent in Lower Limb orthopedic surgery Control Intervention1: Nalbhuphine with Hyperbaric Bupivacaine: Dose 0.5ml containing 1mg of Nalbhupine Hydrochloride is used with 3ml of 0.5 percent hyperbaric Bupivacaine Route Intrathecally Frequency Single Dose, once during Spinal Anesthesia Duration 10 Seconds Corresponding to time required for slow Intrathecal injection Control Intervention2: Fentanyl with hyperbaric bupivacaine: Dose 0.5ml containing 25ug of Fentanyl is used with 3ml of 0.5 percent hyperbaric Bupivacaine Route Intrathecally Frequency Single Dose, once during Spinal Anesthesia Duration 10 Seconds Corresponding to time required for slow intrathecal injection CONDITION: Health Condition 1: S80‐S89‐ Injuries to the knee and lower leg PRIMARY OUTCOME: To Compare the duration and quality of both intraoperative anesthesia and post operative analgesiaTimepoint: Baseline ; Immediately After Block ; Every 5 minutes till 1st 30mins ; Every 30 minutes Postoperatively till 4hours ; and Hourly till 8 hours,12 hours ; SECONDARY OUTCOME: To assess hemodynamic stability ; To assess Post Operative pain using VAS Score & total analgesic requirement in 1st 24 hours ; To compare the incidence & profile of side effectsTimepoint: Baseline ; Immediately After Block ; Every 5 minutes till 1st 30mins ; Every 30 minutes Postoperatively till 4hours ; Every Hourly till 8hours, 12 hours ; INCLUSION CRITERIA: ASA I and ASA II patients posted for lower limb orthopaedic surgery under spinal anesthesia No known history of allergy, sensitivity, or other form of reactions to Local Anesthetics Patients willing to sign informed consent
Epistemonikos ID: 4bc9bada1e226f461bc9f744354daf553fe3a010
First added on: Oct 08, 2026