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

NCT ID: NCT07114237

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-12-30

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.

Detailed Description

Opioid analgesic drugs have been the most commonly used perioperative pain-relieving medications for a very long time. While they are effective at relieving somatic pain they, unfortunately, do not eliminate neuropathic pain and have a profound potential for developing addiction.

The most significant opioid side effect is respiratory depression. This is especially important in patients with obesity, sleep apnea, chronic obstructive pulmonary disease and operations that are associated with a high incidence of post-operative respiratory failure.

Opioid may also induce post-operative nausea and vomiting , pruritus, urine retention, postoperative delirium. Furthermore, opioids depress cell mediated immunity and, in some studies, opioids have been found to be associated with an increased tumor recurrence rate after cancer surgery.

Opioid-free anesthesia has become more and more popular among anesthesiologists around the world. It is an emerging technique and a recent research perspective based on the idea that avoiding intraoperative opioids would be associated with better postoperative outcomes. It allows opioid-sparing and better outcomes than morphine administered as a sole analgesic agent after surgery. Opioid-free anesthesia is based on the same concept, as one drug will not replace opioids. It is the association of drugs and/or techniques that allows a good quality general anesthesia with no need for opioids. Dexmedetomidine is an alpha-2 agonist with analgesic action. Unlike opioids it is not associated with significant respiratory depression, post-operative nausea and vomiting, pruritus, constipation, ileus or delirium.

In laparoscopic surgeries, it has been found to provide adequate analgesia when used as the only analgesic. It provides enhanced recovery and patient satisfaction after laparotomy and should be considered as part of any enhanced recovery after surgery program.

Transversus abdominis plane block is a regional anesthesia technique that involves injecting a local anesthetic into the transversus abdominis plane. It is a triangular fascial plane located between the internal oblique (IO) and the transversus abdominis muscles.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group I: Opioid Free Anesthesia group

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

Group Type: EXPERIMENTAL

Opioid Free Anesthesia

Intervention Type: PROCEDURE

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

Group II: Control group

patients will receive conventional general anesthesia

Group Type: PLACEBO_COMPARATOR

Control group (general anesthesia)

Intervention Type: PROCEDURE

patients will receive conventional general anesthesia

Interventions

Opioid Free Anesthesia

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

Intervention Type: PROCEDURE

Control group (general anesthesia)

patients will receive conventional general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 50 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Merihan Alaa Eldin Ahmed

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merihan Ahmed, Resident

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Central Contacts

Merihan Ahmed, Resident

Role: CONTACT

mere4444.ma@gmail.com

+20 11 11246871

Facility Contacts

Merihan Ahmed, Resident

Role: primary

mere4444.ma@gmail.com

+20 11 11246871

Other Identifiers

36264MS694/9/24

Identifier Type: -

Identifier Source: org_study_id