Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

NCT04039321 | Completed

• 1 other identifier: 13/22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Erector spina plane block; Laparoscopic sleeve gastrectomy; Obesity; Postoperative pain; Pulmonary functions

Outcome Measures

Primary Outcomes (2)

• pulmonary function test

  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.

  perioperative

• analgesia consumption

  postoperative 24 hours

  24 hours

Secondary Outcomes (2)

• Postoperative Numeric Rating Scale (NRS) score

  postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours

• arterial blood gases

  during the surgery

Study Arms (2)

ESPB 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. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.

Drug: ESPB group

Control group

SHAM COMPARATOR

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.

Drug: Control group

Interventions

ESPB group DRUG

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 outplane 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.

ESPB group

Control group DRUG

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:

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

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
• patients with severe obstructive or restrictive lung disease

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, 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

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

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: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: July 31, 2019
• Study Start: August 1, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)