Clinical trial NCT05020379: The Effects of Erector Spinae Plane Block on Bariatric Surgery.
Official title: Investigation of The Effects of The Erector Spinae Plane Block on The Quality Of Recovery After Laparoscopic Bariatric Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Bariatric Surgery
Keywords: Barıatrıc Surgery.
Erector spinae block
Quality of recovery (QoR-40)
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Intervention Model: Parallel Assignment
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery (QoR-40) score
timeFrame: postoperative 24th hour
Secondary outcomes:
measure: Postoperative pain: numeric rating scale (NRS)
timeFrame: Postoperative 48 hour
measure: Analgesic consumption
timeFrame: Postoperative 48 hour
measure: Side effects
timeFrame: 24 hours
measure: Sedation score
timeFrame: Postoperative 48 hour
measure: mobilization time
timeFrame: Postoperative 24 hour
measure: Quality of Recovery (QoR-40) score
timeFrame: Postoperative 3rd and 7th days
measure: Postoperative complications
timeFrame: Postoperative 30 days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betul Basaran, MD, DESA
role: STUDY_DIRECTOR
References: