The Effect of Opioid Free Anesthesia Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion

NCT07114237 | Not Yet Recruiting

• 1 other identifier: 36264MS694/9/24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.

Conditions

Anesthesia; Opioid; Gynecological Surgery

Keywords

Gynecological Surgeries; Opioid Free Anesthesia; Morbid Obese; Dexmedetomidine Infusion

Outcome Measures

Primary Outcomes (1)

• quality of recovery on postoperative day

  The Quality of Recovery-40 questionnaire scores. The Quality of Recovery-40 questionnaire includes five dimensions of recovery: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items).

  one day

Secondary Outcomes (1)

• Postoperative pain severity

  24 HOURS

Study Arms (2)

Group I: Opioid Free Anesthesia group

EXPERIMENTAL

patients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block

Procedure: Opioid Free Anesthesia

Group II: Control group

PLACEBO COMPARATOR

patients will receive conventional general anesthesia

Procedure: Control group (general anesthesia)

Interventions

Opioid Free Anesthesia PROCEDURE

patients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block.

Group I: Opioid Free Anesthesia group

Control group (general anesthesia) PROCEDURE

patients will receive conventional general anesthesia

Group II: Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients aged 21-65 years.
• Patients with a Body mass index≥ 35 kg/m2
• American society of Anesthesiology class II-III.
• Undergoing elective gynecological surgeries.

You may not qualify if:

• Patient refusal.
• History of allergy to local anesthetic.
• Liver or renal pathology affecting drug elimination.
• Mental dysfunction or cognitive disorders.
• Patients on chronic pain medications.
• Hypotension, bradycardia, atrioventricular block, intraventricular or sinoatrial block.
• Coagulopathy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Interventions

Control Groups; Anesthesia, General

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anesthesia; Anesthesia and Analgesia

Study Officials

• Merihan Ahmed, Resident

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merihan Ahmed, Resident

CONTACT

+20 11 11246871; mere4444.ma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)