Dexamethasone As Adjuvant for Pre - emptiveTransversusAbdominus Muscle Plane Block

NCT ID: NCT06970548

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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 Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: 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.

Group B: Control Group

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.

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: 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.

Interventions

Levobupivacaine

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.

Intervention Type: DRUG

Other Intervention Names

Dexamethazone

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Samir Esmail

Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed hamody Hassan

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Other Identifiers

Bariatric surgery

Identifier Type: -

Identifier Source: org_study_id