Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

Dexmedetomidine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229054
• Other study ID #: DEX in obturator nerve block
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: KARIM HUSSEIN, MD
• Phone: 0100741161
• Email: karim.ghaleb87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 0.5% 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 1.5cm lateral and 1.5cm 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 ramus.(15)

• 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 0,2 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Participants will be adults (above 18 years) scheduled to undergo transurethral surgery under regional anesthesia.

• ASA1, ASA2

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) physical class 3,4, severe cardiac comorbidity (impaired contractility with ejection fraction less than 50%, heart block, significant arrhythmias, tight valvular lesions), allergy to any study's drugs

Related Conditions & MeSH terms

• Dexmedetomidine

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine (DEX), an a2-agonist with more promising pharmacokinetic and pharmacodynamic characteristics than clonidine has been proved to have a positive effect on postoperative pain intensity and to reduce opioid consumption
• Bupivacaine Hydrochloride
local anesthesic which works through blocking sodium channels

Locations

Country	Name	City	State
Egypt	Faculty of Medicine-Cairo Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Abdulatif M, Mukhtar A, Obayah G. Pitfalls in reporting sample size calculation in randomized controlled trials published in leading anaesthesia journals: a systematic review. Br J Anaesth. 2015 Nov;115(5):699-707. doi: 10.1093/bja/aev166. Epub 2015 Jun 3. — View Citation

Badrinath R., Konety MD, MBA, Peter R., Carroll MD: Urothelial carcinoma in Smith's General Urology, edited by Emil A. Tanagho, Jack W., and MC Ninch (Eds.), 17th edition, MC Graw Hil, 2008.

Bilotta F, Pugliese F. The evolving clinical use of dexmedetomidine. Lancet. 2020 Jul 18;396(10245):145-147. doi: 10.1016/S0140-6736(20)30902-8. No abstract available. — View Citation

Erbay G, Akyol F, Karabakan M, Celebi B, Keskin E, Hirik E. Effect of obturator nerve block during transurethral resection of lateral bladder wall tumors on the presence of detrusor muscle in tumor specimens and recurrence of the disease. Kaohsiung J Med Sci. 2017 Feb;33(2):86-90. doi: 10.1016/j.kjms.2016.11.006. Epub 2016 Dec 30. — View Citation

Peter T. Nich, MD; Fray F. Marshall, MD Surgery for bladder cancer. Walsh, Patrick C., Retik, Alan B., E. Darracott Vaughan, and Alan J. Wein [Eds]: Campbell's Urology, 9th ed. Philadelphia: Saunders, 2007. 2478

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries	the VAS score consists of 10cm line where 0 represents NO PAIN and 10 represents SEVEREST FORM OF PAIN	24 hours postoperatively
Secondary	• Perioperative analgesic consumption, which will be calculated as the total amount of opioids administered in the postoperative periods.		24 hours postoperative
Secondary	• Incidence of adverse effects as bleeding and bladder perforation.		24 hours postoperative
Secondary	• Incidence of adductor jerk reflex		intraoperative