Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229054
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2024-01-19
Brief Title:
Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Efficacy of Dexmedetomidine as an Adjuvant in Obturator Nerve Block for Postoperative Pain in Patients Undergoing Transurethral Surgeries Under Spinal Anesthesia A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
in our study we will investigate the impact of adding dexmedetomidine to bupivacaine for the potency of the obturator nerve block and prevention of the postoperative pain associated with transurethral surgery in comparison of obturator nerve block with bupivacaine alone
Detailed Description:
After history taking and examination of the labs and airway of the patient An intravenous catheter will be secured in the dorsum of the hand of non dominant hand and patients will be monitored for heart rate noninvasive blood pressure and oxygen saturation
All patients after aseptic preparation will receive subarachnoid block in lumber 3-4 or 4-5 space in sitting position
About 3 ml 15mg of heavy 05 bupivacaine will be injected into subarachnoid space
After the completion of the block patients will be laid in the supine position and subsequently waited for 5 min for fixation of drug and assessed for sensorimotor block
Further procedure will be performed as per the group allocation
ONB will be performed by classic technique 15cm lateral and 15cm caudal to the pubic tuberacle after contact with the pubic ramus is made the needle is redirected laterally to a point 2-3 cm deeper than the pubic ramus15
A waiting period 20 min will be allowed for the full effect of the block and then resection will be allowed to perform
Hemodynamics heart rate mean arterial blood pressure will be recorded intraoperatively and postoperative at 0 2 and 6 hours
VAS score at 02 and 6 hours post-operatively will be assessed
Time to first call for analgesic requirements duration of analgesia will be measured
Total postoperative analgesic consumption in the first 24 hours post-operative will be measured
Incidence of complications such as nerve injury hematoma formation local anesthetic toxicity intravascular injection bleeding and bladder perforation will be assessed
All patients after aseptic preparation will receive subarachnoid block in lumber 3-4 or 4-5 space in sitting position
About 3 ml 15mg of heavy 05 bupivacaine will be injected into subarachnoid space
After the completion of the block patients will be laid in the supine position and subsequently waited for 5 min for fixation of drug and assessed for sensorimotor block
Further procedure will be performed as per the group allocation
ONB will be performed by classic technique 15cm lateral and 15cm caudal to the pubic tuberacle after contact with the pubic ramus is made the needle is redirected laterally to a point 2-3 cm deeper than the pubic ramus15
A waiting period 20 min will be allowed for the full effect of the block and then resection will be allowed to perform
Hemodynamics heart rate mean arterial blood pressure will be recorded intraoperatively and postoperative at 0 2 and 6 hours
VAS score at 02 and 6 hours post-operatively will be assessed
Time to first call for analgesic requirements duration of analgesia will be measured
Total postoperative analgesic consumption in the first 24 hours post-operative will be measured
Incidence of complications such as nerve injury hematoma formation local anesthetic toxicity intravascular injection bleeding and bladder perforation will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None