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Ibuprofen and Erector Spinae Plane Block After Laparoscopic Sleeve Gastrectomy

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232072
Enrollment
0
Registered
2020-01-18
Start date
2020-02-11
Completion date
2020-11-30
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Ibuprofen, Erector spina plane block, Postoperative analgesia management, Laparoscopic sleeve gastrectomy

Brief 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.

Detailed 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).

Interventions

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.

OTHERGroup 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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The anesthesiologist who performs postoperative pain evaluation will not know the group.

Intervention model description

There are three models for this study. The first group is erector spinae plane block group, the second one is intravenous ibuprofen group, the third group is the no intervention control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumptionChanges from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.The primary aim is to compare postoperative opioid consumption

Secondary

MeasureTime frameDescription
Pain scores (Visual analogue scores-VAS)Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours.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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026