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This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.
The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol group | Active Comparator | Intrathecal tramadol 20mg + bupivacaine 0.5% |
|
| Intrathecal nalbuphine | Experimental | Intrathecal nalbuphine 1 mg + bupivacaine 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal tramadol with spinal anesthsia | Drug | intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of spinal anesthesia | Time until first rescue analgesia at VAS <4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible) | up to 24 hours post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital Lahore | Lahore | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35340949 | Background | Sharma A, Chaudhary S, Kumar M, Kapoor R. Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):529-536. doi: 10.4103/joacp.JOACP_270_18. Epub 2022 Jan 6. |
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| Intrathecal nalbuphine and spinal anesthesia | Drug | intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine |
|
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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