Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-01

Brief Summary

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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

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Detailed Description

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* 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.

Conditions

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Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 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 Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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

Bupivacaine Hydrochloride

Intervention Type DRUG

local anesthesic which works through blocking sodium channels

group Bupivacaine

: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 Type OTHER

Bupivacaine Hydrochloride

Intervention Type DRUG

local anesthesic which works through blocking sodium channels

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Bupivacaine Hydrochloride

local anesthesic which works through blocking sodium channels

Intervention Type DRUG

Other Intervention Names

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DEX marcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes