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Completed

NCT Number: NCT06970548

Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block

Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent . Most morbidly obese patients also have obstructive sleep apnea and associated with cardiac co-morbidities. Prolonged postoperative pain in them may lead to delay in early ambulation and performing deep breathing exercises.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

About this study

Pain following bariatric surgery can be quite troublesome and prolongs recovery. Although laparoscopic bariatric surgery is minimally invasive and involves small incisions over the anterior abdominal wall, postoperative pain is frequent.

This this increases incidence of deep vein thrombosis and risk of pulmonary complications respectively. Because postoperative recovery is directly associated with the intensity and duration of pain, it is imperative to reduce the postoperative pain as early as possible. A substantial component of pain experienced by patients undergoing laparoscopic surgery is somatic pain arising from the port sites over the abdominal wall.

Many methods have been suggested for reducing the postoperative abdominal wall pain such as port site instillation of local anesthetics, patient-controlled analgesia (PCA), epidural catheterization, and use of non-steroidal anti-inflammatory drugs (NSAIDS). Opioid analgesics to counter immediate acute postoperative pain are known to cause postoperative nausea and vomiting (PONV).

The average reported incidence of PONV in immediate postoperative period in patients undergoing bariatric surgery is between 30 and 50% [5]. This contributes to increased costs, increased length of stay, increased perioperative morbidity, and prolonged overall recovery [6]. Systemically administered opioids also depress respiratory drive, level of consciousness, and supraglottic airway muscle tone resulting in hypoxia and hypercapnia.

The TransversusAbdominis Plane (TAP) block is a loco-regional analgesia technique that consists of infiltrating a local anesthetic solution between the plane of the transversus-abdominis muscle and the internal oblique muscle, laterally at the level of the triangle of Petit. The sensory nerves of the abdominal wall pass through this plane. This technique produces long-lasting analgesia, between 24-36 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 40 patients with American Society of Anesthesiologists (ASA) grade I to II, 20 to 65 years of age scheduled for Laparoscopic Sleeve Gastrectomy.

Exclusion criteria

  • patient refusal.
  • Chronic alcoholism
  • Chronic opioid usage
  • ASA Grade 4 or more
  • Chronic kidney disease
  • Chronic liver disease
  • Chronic obstructive pulmonary disease.
  • Known allergy to study medications.
  • Pregnancy.

Treatment and study plan

Levobupivacaine

Drug

To evaluate efficacy of addition of dexamethasone to levopubivacaine in tranversusabdominis plane block (TAP) in postoperative pain management, postoperative analgesic consumption, and patient comfort after laparoscopic bariatric surgery.

Other names: Dexamethazone

Primary outcomes

  1. Postoperative Pain Relief

    Time frame: from 0 hours to 6 hours after the procedure

    Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block In Patient Undergoing Bariatric Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 14, 2025
Registry last updated
May 14, 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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