Ibuprofen and Erector Spinae Plane Block After Laparoscopic Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

Comparison of Intravenous Ibuprofen and Erector Spinae Plane Block for Postoperative Pain Management After Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04232072
• Other study ID #: Medipol Hospital 8
• Status: Withdrawn
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: November 30, 2020

Study information

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

Clinical Trial Summary

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 intravenous (IV) form of ibuprofen has been used in the pain treatment since 2009. It has been shown to be effective, safe and with less adverse effects in the treatment of postoperative pain. It has been reported that ibuprofen provides effective postoperative pain management after LSG surgery.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level. In the literature, it has been reported that ESPB provides effective analgesia after LSG surgery.

The aim of this study is to compare US-guided ESPB and IV ibuprofen for postoperative analgesia management after LSG surgery.

Description:

Bariatric surgery has been widely used in the treatment of obesity in recent years. 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. Therefore, the American Society of Anesthesiologists (ASA) recommends the use of multimodal analgesia including local anesthesia, regional anesthesia and nonsteroidal anti-inflammatory drugs (NSAIDs).

NSAIDs have long been used in the treatment of pain and inflammation. Ibuprofen is a propionic acid derivative that has anti-inflammatory, antipyretic, and analgesic effects similar to other NSAIDs. The intravenous (IV) form of ibuprofen has been used in the pain treatment since 2009. It has been shown to be effective, safe and with less adverse effects in the treatment of postoperative pain. It has been reported that ibuprofen provides effective postoperative pain management after LSG surgery.

The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. The ESPB 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. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level. In the literature, it has been reported that ESPB provides effective analgesia after LSG surgery.

The aim of this study is to compare US-guided ESPB and IV ibuprofen for postoperative analgesia management after LSG surgery. 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: November 30, 2020
• Est. primary completion date: November 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 surgery under general anesthesia

Exclusion Criteria:

• history of 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:
• Group ESPB
A dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. At the end of the surgery, local anesthetic infiltration will be perfomed around the port entrance sites by the surgical team to the all patients. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit at the postoperative period.
• Group Ibuprofen
A dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. At the end of the surgery, local anesthetic infiltration will be perfomed around the port entrance sites by the surgical team to the all patients. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit at the postoperative period. In Group Ibuprofen, patients will be administered ibuprofen 800 mgr IV every 8 hours in the postoperative period.

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, 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

Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1. — 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	The primary aim is to compare postoperative opioid consumption	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary	Pain scores (Visual analogue scores-VAS)	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 mobilization will be recorded	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours.