The Effects of Erector Spinae Plane Block on Bariatric Surgery.

Investigation of The Effects of The Erector Spinae Plane Block on The Quality Of Recovery After Laparoscopic Bariatric Surgery: A Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Bariatric Surgery
• Intervention / Treatment: Procedure: Perioperative and postoperative multimodal analgesia; Procedure: ESP Block

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group N; The patients in Group N will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS are the simple and most commonly used scales.11 The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	Procedure: Perioperative and postoperative multimodal analgesia; Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.; Other Names: Global Quality of Recovery-40 score; Standard Pain Follow up
Experimental: Group ESPB; The patients in the group ESPB will be placed in sitting pozition. A convex probe ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS)	Procedure: Perioperative and postoperative multimodal analgesia; Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol. The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.; Other Names: Global Quality of Recovery-40 score; Standard Pain Follow up; Procedure: ESP Block; 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. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep face of the erector spinae muscle. 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 evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.; Other Names: Global Quality of Recovery-40 score; Standard Pain Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery (QoR-40) score	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 24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: numeric rating scale (NRS)	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	Postoperative 48 hour
Analgesic consumption	Total opioid consumption at the postoperative period	Postoperative 48 hour
Side effects	Rate of side-effect occurrences (such as rate of vomiting,nausea,dizziness)	24 hours
Sedation score	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 48 hour
mobilization time	The time after surgery to the mobilization of the patient	Postoperative 24 hour
Quality of Recovery (QoR-40) score	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 3rd and 7th days
Postoperative complications	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.	Postoperative 30 days

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 21, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Barıatrıc Surgery.; Erector spinae block; Quality of recovery (QoR-40)
• Other Study ID Numbers: 05-2021/05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No