Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Control group; Drug: ESPB group

• Registration Number: NCT04039321
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.

Detailed Description

Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.

The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.

In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.

Study Timeline

• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Study Start: 2019-08-01
• Status Verified: 2019-12
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

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

Inclusion Criteria

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

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
• patients with severe obstructive or restrictive lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.
ESPB group	ESPB 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. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.

Primary Outcome Measures

Name	Time	Method
analgesia consumption	24 hours	postoperative 24 hours
pulmonary function test	perioperative	Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation. Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.

Secondary Outcome Measures

Name	Time	Method
arterial blood gases	during the surgery	intraoperative
Postoperative Numeric Rating Scale (NRS) score	postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours	postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12, 18 and 24 hours

Trial Locations

Locations (1)

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