Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Levobupivacaine

• Registration Number: NCT06970548
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-06-01
• Primary Completion: 2023-05-20
• Study Completion: 2023-06-01
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Levobupivacaine	About 20 patients received Ultrasound-guided (USG-TAP) block with 40 ml of 0.375% levobupivacaine plus 8ml dexamethasone. All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant.The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h.
Group B: Control Group	Levobupivacaine	About 20 patients received only (USG-TAP) by 40 ml 0.375% levobupivacaine.All participants then evaluated preoperatively by multidisciplinary team consist of internal medicine, nutritionist, psychotherapist, surgeon and anesthetist. And also they received standard general anesthesia technique with endotracheal intubation and muscle relaxant. The patients will be given 1-2 mg of midazolam intra venous as a premedication about 20 min before induction of general anesthesia. Standard monitoring included continuous electrocardiography (ECG), pulse oximetry, capnography and noninvasive blood pressure. General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 3 μg/kg. Tracheal intubation will be facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane 1MAC, cis-atracurium 2 μg/kg/min and fentanyl 1 μg/kg/h.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Relief	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.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt