NCT03824665|CompletedPhase 4DMC
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Sponsor study identifier
interventional
120
1 country
1
Study Start
February 5, 2019
Actual (reported)Primary Completion
May 10, 2019
Actual (reported)Study Completion
May 18, 2019
Actual (reported)Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal,epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia. The aim of this study is evaluation of the effect of 4 mg Nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing posterior chamber surgery in adult patients and comparing it with adding Fentanyl 20 μg to LAM and LAM alone
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 18, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2019
Actual (reported)January 31, 2019
Actual (reported)February 5, 2019
Actual (reported)May 10, 2019
Actual (reported)May 18, 2019
Actual (reported)Onset of eyelid and globe akinesia
The onset of eyelid and globe akinesia was assessed till complete recovery
24 hours Postoperative
Blood pressure
24 hours Postoperative
Heart rate
24 hours Postoperative
Post Operative analgesia
24 hours Postoperative
Nalbuphine Group (Nalbuphine) 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 4mg nalbuphine
Fentanyl Group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml saline containing 20 μg fentanyl
Control group 8 ml of LAM which consisted of: 6 ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, plus 1 ml normal saline
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline
Ahmed Abdalla Mohamed
Cairo, 11451, Egypt
Ahmed Abdalla Mohamed, M.D
Cairo University
120 participants (actual enrollment reported by the registry).
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline
All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive Patients were categorized into three groups according to the type of additive used with the LAM as follows: Group C (Control group): included patients assigned to receive 1 ml normal saline.
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First Submitted
January 19, 2019
First Posted
January 31, 2019
Study Start
February 5, 2019
Actual (reported)Primary Completion
May 10, 2019
Actual (reported)Study Completion
May 18, 2019
Actual (reported)Last Updated
May 21, 2019
Record last verified: 2019-05
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