Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

Obesity Clinical Trial

Official title:

Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189289
• Other study ID #: 21/16
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: April 6, 2020

Study information

• Verified date: December 2019
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 6, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• ESP block group
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.
• Control group
The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesia consumption	postoperative 24 hours	24 hours
Secondary	Postoperative Numeric Rating Scale (NRS) score	postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible).	postoperative 0, 1, 3, 6, 12, 24 hours