Ultrasound-Guided Erector Spinae Plane Block Following Laparoscopic Sleeve Gastrectomy Surgery

Obesity Clinical Trial

Official title:

The Efficacy Of Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia Management Following Laparoscopic Sleeve Gastrectomy Surgery: A Prospective, Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03921970
• Other study ID #: Medipol Mega Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2021
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery has been widely used in the treatment of obesity in recent years. It has been shown to be effective in reaching the ideal weight and reducing obesity-induced comorbidities. Laparoscopic sleeve gastrectomy (LSG) is defined as the first-step bariatric surgery for patients in the high surgical risk group. It has been shown that the laparoscopic approach has lower complication rates, shorter hospital stays, and earlier mobilization compared to open surgery. However, postoperative pain management is very important because it might cause major morbidity, especially pulmonary complications in the early postoperative period. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after laparoscopic sleeve gastrectomy surgery.

Description:

Prospective, Randomized Study Bariatric surgery has been widely used in the treatment of obesity in recent years. It has been shown to be effective in reaching the ideal weight and reducing obesity-induced comorbidities. Laparoscopic sleeve gastrectomy (LSG) is defined as the first-step bariatric surgery for patients in the high surgical risk group. It has been shown that the laparoscopic approach has lower complication rates, shorter hospital stays, and earlier mobilization compared to open surgery. However, postoperative pain management is very important because it might cause major morbidity, especially pulmonary complications in the early postoperative period. General recommendations for bariatric surgery include multimodal analgesia without sedatives, local analgesic infiltration, and early mobilization. Opioid analgesics are often preferred for pain management because of their strong analgesic potentials. However, opioids have undesirable adverse effects such as sedation, dizziness, constipation, nausea, vomiting, physical dependence and addiction, hyperalgesia, immunologic and hormonal dysfunction, muscle rigidity, tolerance, and respiratory depression. The morbidly obese patients treated with opioids experience increased risk for adverse effects such as atelectasis, which causes postoperative pulmonary complications, and obstructive sleep apnea, which causes hypoxemia, postoperative ileus and longer hospital stay due to nausea and vomiting. For this reason, in 2006, the American Society of Anesthesiologists (ASA) suggested minimizing or avoiding opioids during perioperative and/or postoperative pain management to the bariatric patients. Therefore, ASA recommends the use of multimodal analgesia including local anesthesia, regional anesthesia and nonsteroidal anti-inflammatory drugs (NSAIDs). The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. The ESP block contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both posterior and anterolateral thorax. In the literature, it has been reported that ESP block provides effective analgesia after ventral hernia repair surgery in a randomized controlled study. In some case series and case reports it has been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after laparoscopic sleeve gastrectomy surgery. The aim of this study is to evaluate the efficacy of US-guided ESP block for postoperative analgesia management following laparoscopic sleeve gastrectomy. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for laparoscopic sleeve gastrectomy under general anesthesia

Exclusion Criteria:

• Bleeding diathesis
• Receiving anticoagulant treatment
• Known local anesthetics and opioid allergy
• Infection of the skin at the site of the needle puncture
• Pregnancy or lactation
• Patients who do not accept the procedure

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• ESP block (Group ESP)
Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — View 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. — View Citation

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption by the patients at postoperative 24 hours peirod	Fentanyl using	Postoperative 24 hours
Secondary	Postoperative pain scores	Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16 and 24 hours.	Postoperative 24 hours period