Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

Not Applicable

Completed

• Conditions: Postoperative Pain; Bariatric Surgery; Obesity
• Interventions: Procedure: ESP block group; Procedure: Control group

• Registration Number: NCT04189289
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Detailed Description

Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression.

The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery.

The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-03
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-06
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• elective bariatric surgery
• American Society of Anesthesiology (ASA) II-III
• 18 - 65 years
• body mass index (BMI) 40-60 kg/m2

Exclusion Criteria

• ASA ≥4
• under 18 years of age or over 65 years of age
• declining to give written informed consent
• have neurological and/or psychiatric disorders
• cooperation cannot be established
• accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
• history of bariatric surgery
• the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
• with hepatic, neuromuscular, cardiac and/or renal failure
• history of allergy to the local anesthetics
• patients undergoing open surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block group	ESP block group	Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. patient controlled analgesia (PCA) protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion).
Control group	Control group	Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. Standardized postoperative tramadol i.v. PCA analgesia protocol will be performed (3 mg/ml, total volume 100 ml, 10 mg bolus dose, 20 min locked period, without continuous delivery, no basal infusion).

Primary Outcome Measures

Name	Time	Method
analgesia consumption	24 hours	postoperative 24 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative Numeric Rating Scale (NRS) score	postoperative 0, 1, 3, 6, 12, 24 hours	postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).

Trial Locations

Locations (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation; 🇹🇷 Antalya, Turkey