## Protocol Section
### Identification Module
**NCT ID:** NCT05020379

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 05-2021/05
#### Organization
**Class:** OTHER
**Full Name:** Karaman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2022-10-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-28

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09-27

**Type:** ACTUAL

#### Start Date
**Date:** 2021-09-10

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2021-08-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-21
**Study First Submit QC Date:** 2021-08-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karaman Training and Research Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Laparoscopic Bariatric Surgery

**Keywords:**

- Barıatrıc Surgery.

- Erector spinae block

- Quality of recovery (QoR-40)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized Intervention Model: Parallel Assignment

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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."

**Intervention Names:**

- Procedure: Perioperative and postoperative multimodal analgesia

**Label:** Group N

**Type:** SHAM_COMPARATOR

#### Arm Group 2

**Description:** 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)

**Intervention Names:**

- Procedure: Perioperative and postoperative multimodal analgesia

- Procedure: ESP Block

**Label:** Group ESPB

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group ESPB

- Group N

**Description:** 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.

**Name:** Perioperative and postoperative multimodal analgesia

**Other Names:**

- Global Quality of Recovery-40 score

- Standard Pain Follow up

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group ESPB

**Description:** 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.

**Name:** ESP Block

**Other Names:**

- Global Quality of Recovery-40 score

- Standard Pain Follow up

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Quality of Recovery (QoR-40) score

**Time Frame:** postoperative 24th hour

#### Secondary Outcomes

**Description:** 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

**Measure:** Postoperative pain: numeric rating scale (NRS)

**Time Frame:** Postoperative 48 hour

**Description:** Total opioid consumption at the postoperative period

**Measure:** Analgesic consumption

**Time Frame:** Postoperative 48 hour

**Description:** Rate of side-effect occurrences (such as rate of vomiting,nausea,dizziness)

**Measure:** Side effects

**Time Frame:** 24 hours

**Description:** 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).

**Measure:** Sedation score

**Time Frame:** Postoperative 48 hour

**Description:** The time after surgery to the mobilization of the patient

**Measure:** mobilization time

**Time Frame:** Postoperative 24 hour

**Description:** 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.

**Measure:** Quality of Recovery (QoR-40) score

**Time Frame:** Postoperative 3rd and 7th days

**Description:** 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.

**Measure:** Postoperative complications

**Time Frame:** Postoperative 30 days

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Karaman

**Country:** Turkey

**Facility:** Karaman Training and Research Hospital

**Zip:** 70200

#### Overall Officials

**Official 1:**

**Affiliation:** Karaman Training and Research Hospital

**Name:** Betul Basaran, MD, DESA

**Role:** STUDY_DIRECTOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M16901

- Name: Tramadol

- Relevance: LOW

- As Found: Unknown

- ID: M244991

- Name: Tenoxicam

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
