Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

Early Phase 1

Completed

• Conditions: Dexmedetomidine
• Interventions: Drug: Dexmedetomidine; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT06229054
• Lead Sponsor: Cairo University

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 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.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-01
• Primary Completion: 2024-07-20
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Dexmedetomidine	Dexmedetomidine	: 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).
group Bupivacaine	Bupivacaine Hydrochloride	: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).
group Dexmedetomidine	Bupivacaine Hydrochloride	: 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).

Primary Outcome Measures

Name	Time	Method
Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries	24 hours postoperatively	the VAS score consists of 10cm line where 0 represents NO PAIN and 10 represents SEVEREST FORM OF PAIN

Secondary Outcome Measures

Name	Time	Method
• Perioperative analgesic consumption, which will be calculated as the total amount of opioids administered in the postoperative periods.	24 hours postoperative	to detect incidence of pain postoperative
• Incidence of adductor jerk reflex	intraoperative	to detect incidience of jerk reflex during the surgery
• Incidence of adverse effects as bleeding and bladder perforation.	24 hours postoperative	to detect any complications occured during the surgery

Trial Locations

Locations (1)

Faculty of Medicine-Cairo Univeristy; 🇪🇬 Cairo, Egypt