The Effects of Erector Spinae Plane Block on Bariatric Surgery.

NCT05020379 | Completed

• 1 other identifier: 05-2021/05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Bariatric Surgery

Keywords

Barıatrıc Surgery.; Erector spinae block; Quality of recovery (QoR-40)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative pain: numeric rating scale (NRS)

  Postoperative 48 hour

• Analgesic consumption

  Postoperative 48 hour

• Side effects

  24 hours

• Sedation score

  Postoperative 48 hour

• mobilization time

  Postoperative 24 hour

Study Arms (2)

Group N

SHAM COMPARATOR

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

Group ESPB

EXPERIMENTAL

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; Procedure: ESP Block

Interventions

Perioperative and postoperative multimodal analgesia PROCEDURE

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.

Also known as: Global Quality of Recovery-40 score, Standard Pain Follow up

Group ESPB; Group N

ESP Block PROCEDURE

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.

Also known as: Global Quality of Recovery-40 score, Standard Pain Follow up

Group ESPB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective laparoscopic bariatric surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Toprak H, Basaran B, Toprak SS, Et T, Kumru N, Korkusuz M, Bilge A, Yarimoglu R. Efficacy of the Erector Spinae Plane Block for Quality of Recovery in Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2023 Sep;33(9):2640-2651. doi: 10.1007/s11695-023-06748-3. Epub 2023 Jul 24.

  PMID: 37488349 DERIVED

Study Officials

• Betul Basaran, MD, DESA

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 25, 2021
• Study Start: September 10, 2021
• Primary Completion: September 27, 2022
• Study Completion: October 27, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

TU (1)