Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

August 9, 2024 updated by: Karim Hussein, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Faculty of Medicine-Cairo Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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
Other Names:
  • DEX
Drug: Bupivacaine Hydrochloride
local anesthesic which works through blocking sodium channels
Other Names:
  • marcaine
Other: 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).
Drug: Bupivacaine Hydrochloride
local anesthesic which works through blocking sodium channels
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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
24 hours postoperative
• Incidence of adverse effects as bleeding and bladder perforation.
Time Frame: 24 hours postoperative
to detect any complications occured during the surgery
24 hours postoperative
• Incidence of adductor jerk reflex
Time Frame: intraoperative
to detect incidience of jerk reflex during the surgery
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX in obturator nerve block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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