Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

NCT04189289 | Completed

• 1 other identifier: 21/16
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Postoperative Pain; Bariatric Surgery

Keywords

Erector spinae plane (ESP) block; Laparoscopic bariatric surgery; Obesity; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• analgesia consumption

  postoperative 24 hours

  24 hours

Secondary Outcomes (1)

• Postoperative Numeric Rating Scale (NRS) score

  postoperative 0, 1, 3, 6, 12, 24 hours

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

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).

Procedure: ESP block group

Control group

SHAM COMPARATOR

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).

Procedure: Control group

Interventions

ESP block group PROCEDURE

USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an out-plane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.

ESP block group

Control group PROCEDURE

The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

• Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

  PMID: 28272292 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Bites and Stings

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arzu Karaveli

  Antalya TRH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised controlled

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 3, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 6, 2020
• Last Updated: April 8, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)