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NCT Number: NCT07114237

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

opioid free anesthesia

Procedure

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

Control group (general anesthesia)

Procedure

patients will receive conventional general anesthesia

Primary outcomes

  1. quality of recovery on postoperative day

    Time frame: one 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).

Secondary outcomes

  1. Postoperative pain severity

    Time frame: 24 HOURS

    Postoperative pain severity will be assessed by the numerical rating scale ( 0 no pain while 10 is the maximum pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Merihan Ahmed, Resident

CONTACT

[email protected]

+20 11 11246871

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Effect of Opioid Free Anesthesia in Morbid Obese Patient Undergoing Gynecological Surgeries Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion: A Randomized Controlled

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

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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