NCT05041270|Completed
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Sponsor study identifier
interventional
23
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 15, 2022
Actual (reported)Combined spinal epidural anesthesia (CSE) with bupivacaine alone is not sufficient to cover pain sequel during lower limb surgeries. Previous studies used addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia giving a good result in pain control. In this study the investigators will evaluate and compare the addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia to evaluate the analgesic efficacy of either drug.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2021
Actual (reported)September 13, 2021
Actual (reported)October 1, 2021
Actual (reported)April 30, 2022
Actual (reported)May 15, 2022
Actual (reported)Duration of epidural analgesia
time elapsed from epidural injection of LA until VAS score (≥3)
within 24 hour postoperative
Maximum level of sensory blockade
the maximum sensory dermatome level after 30 min of administering the local anesthetic in the epidural space
after 30 min of administering the local anesthetic in the epidural space
number of top up doses required
within 24 hour postoperative
assessment of changes in patient's level of sedation
Sedation scores will be recorded just before the initiation and 2 hours postoperatively
patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 2ml normal saline), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2ml normal saline).
patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 100µg dexmedetomidine in 2ml volume), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 20µg dexmedetomidine in 2ml volume)
Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 2ml normal saline) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2ml normal saline).
faculty of medicine, Zagazig university
Zagazig, Elsharqya, 44519, Egypt
Shruthi AH, Sudheesh K, Nethra SS, Raghavendra Rao RS, Devika Rani D. THE EFFECT OF A SINGLE DOSE OF MAGNESIUM SULPHATE AS AN ADJUVANT TO EPIDURAL BUPIVACAINE FOR INFRAUMBILICAL SURGERIES: A PROSPECTIVE DOUBLE-BLIND, RANDOMIZED CONTROL TRIAL. Middle East J Anaesthesiol. 2016 Feb;23(4):449-55.
Chatrath V, Attri JP, Bala A, Khetarpal R, Ahuja D, Kaur S. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015 Sep-Dec;9(3):326-30. doi: 10.4103/0259-1162.158004.
Howaida A Kamal, MD
Faculty of medicine, zagazig university, Zagazig, Elsharqya, Egypt, 44519
23 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2021
First Posted
September 13, 2021
Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics
patient will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 10mg nalbuphine in 2ml volume), top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2mg nalbuphine in 2ml volume)
Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 100µg dexmedetomidine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 20µg dexmedetomidine in 2ml volume).
Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 10mg nalbuphine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min. top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2mg nalbuphine in 2ml volume).
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Gupta K, Rastogi B, Gupta PK, Singh I, Bansal M, Tyagi V. Intrathecal nalbuphine versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under subarachnoid block: A comparative evaluation. Indian J Pain. 2016; 30:90-5.
Chiruvella S, Donthu B, Nallam SR, Salla DB. Postoperative Analgesia with Epidural Dexmedetomidine Compared with Clonidine following Total Abdominal Hysterectomies: A Prospective Double-blind Randomized Trial. Anesth Essays Res. 2018 Jan-Mar;12(1):103-108. doi: 10.4103/aer.AER_207_17.
Soliman AAM, Melika ASM. Epidural bupivacaine and dexmedetomidine versus bupivacaine and opioids for lower vascular surgery. J Med Sci Res. 2018; 1:158-63.
Paul A, Nathroy A, Paul T. A comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine in lower limb surgeries. J Med Sci. 2017; 37:221-6.
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.
Study Start
October 1, 2021
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 15, 2022
Actual (reported)Last Updated
May 12, 2023
Record last verified: 2023-05
planned after the completion of the study and publication
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