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NCT Number: NCT06229054

Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

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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Key information

Conditions

Dexmedetomidine

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine-Cairo Univeristy

Cairo, 11562, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: DEX

Bupivacaine Hydrochloride

Drug

local anesthesic which works through blocking sodium channels

Other names: marcaine

Primary outcomes

  1. Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries

    Time frame: 24 hours postoperatively

    the VAS score consists of 10cm line where 0 represents NO PAIN and 10 represents SEVEREST FORM OF PAIN

Secondary outcomes

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

    Time frame: 24 hours postoperative

    to detect incidence of pain postoperative

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

    Time frame: 24 hours postoperative

    to detect any complications occured during the surgery

  3. • Incidence of adductor jerk reflex

    Time frame: intraoperative

    to detect incidience of jerk reflex during the surgery

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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