Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block

NCT06970548 | Completed DMC

• 1 other identifier: Bariatric surgery
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Relief

  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.

  from 0 hours to 6 hours after the procedure

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Drug: Levobupivacaine

Group B: Control Group

ACTIVE COMPARATOR

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.

Drug: Levobupivacaine

Interventions

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.

Also known as: Dexamethazone

Group A; Group B: Control Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine; 21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ahmed hamody Hassan

  Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: June 1, 2022
• Primary Completion: May 20, 2023
• Study Completion: June 1, 2023
• Last Updated: May 14, 2025

Record last verified: 2022-05

Locations

EG (1)