Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

Obesity Clinical Trial

Official title:

The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039321
• Other study ID #: 13/22
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 4, 2019

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 spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• ESPB 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 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.
• 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	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
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). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12, 18 and 24 hours	postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours
Secondary	arterial blood gases	intraoperative	during the surgery