The Effects of Erector Spinae Plane Block on Bariatric Surgery.

Not Applicable

Completed

• Conditions: Laparoscopic Bariatric Surgery

• Registration Number: NCT05020379
• Lead Sponsor: Karaman Training and Research Hospital

Brief Summary

The erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Poorly controlled early postoperative pain impairs quality of recovery, increases the risk of postoperative pulmonary complications, and is a risk factor for the subsequent development of chronic pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing bariatric surgery. The primary aim of this prospective, randomized study is to evaluate the effect of ESPB on quality of recovery with the QoR-40 questionnaire in patients undergoing elective Laparoscopic Bariatric Surgery.

Detailed Description

In the operating room, all patients will receive standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation. Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. The needle tip was advanced until it will be located in the inter-fascial plane deep to the erector spinae muscle group and superior to the transverse process. Once in position, bupivacaine 0.25%, 20 ml was injected under ultrasound, guidance. The same procedure will be repeated on the contralateral site. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be recorded on the 15th,30th minute, 1st, 2nd, 12th, 24th hour, 2nd day. Quality of recovery-40 (QoR-40) scores will be given on the ward, at postoperative 24th hour, 3rd and 7th day ( the 3rd and 7th-day scores will be calculated after telephone interview if the patient will be discharged from the hospital).

Study Timeline

• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-21
• Study First Posted: 2021-08-25
• Study Start: 2021-09-10
• Primary Completion: 2022-09-27
• Status Verified: 2022-10
• Study Completion: 2022-10-27
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Scheduled for elective laparoscopic bariatric surgery

Exclusion Criteria

• a history of allergy to local anesthetics
• known coagulation disorders
• infection near the puncture site
• Chronic opioid intake
• Patient with psychiatric disorders
• Can not communicate in Turkish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Recovery (QoR-40) score	postoperative 24th hour	QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.

Secondary Outcome Measures

Name	Time	Method
mobilization time	Postoperative 24 hour	The time after surgery to the mobilization of the patient
Sedation score	Postoperative 48 hour	Evaluation of the level of sedation in patients with a 4-point scale (0=wake, 1=sleepy, easy to verbally arouse, 2=drowsy, 3=does not open their eyes to verbal commands).
Postoperative pain: numeric rating scale (NRS)	Postoperative 48 hour	NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system
Analgesic consumption	Postoperative 48 hour	Total opioid consumption at the postoperative period
Quality of Recovery (QoR-40) score	Postoperative 3rd and 7th days	QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.
Postoperative complications	Postoperative 30 days	Postoperative complications will be identified by visiting patients every day or alternate day during their in hospital course, suplemented by patients medical records using our hospital's electronic patient record database. We will use the Claviene Dindo Classification system from which CC is derived. We defined a postoperative complication as any deviation from the ideal postoperative course, not inherent in the procedure itself and does not constitute a failure to cure. CCI scores willbe calculated using the online CCI calculator.
Side effects	24 hours	Rate of side-effect occurrences (such as rate of vomiting,nausea,dizziness)

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey