Clinical trial NCT04189289: Laparoscopic Bariatric Surgery and Erector Spinae Plane Block
Official title: Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Postoperative Pain
Bariatric Surgery
Keywords: Erector spinae plane (ESP) block
Laparoscopic bariatric surgery
Obesity
Postoperative pain
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: analgesia consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative Numeric Rating Scale (NRS) score
timeFrame: postoperative 0, 1, 3, 6, 12, 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya TRH
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.