Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

NCT06229054 | Completed Early Phase 1 DMC

• 1 other identifier: DEX in obturator nerve block
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Dexmedetomidine

Keywords

obturator nerve block; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• • Perioperative analgesic consumption, which will be calculated as the total amount of opioids administered in the postoperative periods.

  24 hours postoperative

• • Incidence of adverse effects as bleeding and bladder perforation.

  24 hours postoperative

• • Incidence of adductor jerk reflex

  intraoperative

Study Arms (2)

group Dexmedetomidine

EXPERIMENTAL

: Patients in this group will receive regional anesthesia and obturator nerve block bilaterally (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine) and dexmedetomidine 100 mcg/mL (2µg/kg).

Drug: Dexmedetomidine; Drug: Bupivacaine Hydrochloride

group Bupivacaine

OTHER

:Patients in this group will receive regional anesthesia and bilateral obturator nerve block only (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine).

Drug: Bupivacaine Hydrochloride

Interventions

Dexmedetomidine DRUG

Dexmedetomidine (DEX), an α2-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

Also known as: DEX

group Dexmedetomidine

Bupivacaine Hydrochloride DRUG

local anesthesic which works through blocking sodium channels

Also known as: marcaine

group Bupivacaine; group Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be adults (above 18 years) scheduled to undergo transurethral surgery under regional anesthesia.
• ASA1, ASA2

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine-Cairo Univeristy

Cairo, 11562, Egypt

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28137416 BACKGROUND

• 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.

  PMID: 32682463 BACKGROUND

• 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.

  PMID: 26041717 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: July 20, 2024
• Study Completion: August 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)