## Protocol Section
### Identification Module
**NCT ID:** NCT04417179

**Brief Title:** Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery

**Official Title:** The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery

#### Organization Study ID Info
**ID:** MD-250-2020
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2022-02-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-08-20

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2020-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-31
**Study First Submit QC Date:** 2020-06-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** mohamed abdelghany ali

**Investigator Title:** Anesthesia lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study to compare erector spinae block to transversus abdominis plane block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and respiratory complications

**Detailed Description:** The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia for chronic pain and perioperative period. it can provide both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level. ESP block is effective, easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may have comparable or improved analgesic effect in upper and lower abdominal surgical procedures when compared to other suitable plane blocks.

Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block. Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the postoperative requirement of opioid analgesics, decreases the incidence and severity of postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness for discharge postoperatively.

Both blocks is effective in reducing postoperative complication and need of analgesia , To our knowledge there is no comparative study between the two blocks to this population .

the investigators aim to compare the perioperative analgesic effect between TAP block and ES block in bariatric .

### Conditions Module

**Conditions:**

- Erector Spinae Block

- Bariatric Surgery Candidate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the TAP block will be given by a high frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .

a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under direct ultrasound visualization, . After confirming the correct placement of the needle and the negative aspiration probe anaesthetic substance will be injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine(10) , and the dissection of the plane was observed. The block will be performed bilaterally.

**Intervention Names:**

- Procedure: transversus abdominis block

- Drug: Bupivacaine 0.25% Injectable Solution

- Device: Siemens Acuson x300 3-5MHz Ultrasound

**Label:** TAP block group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .A blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under strict aseptic precautions until the tip is deep to erector spinae muscle, The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally

**Intervention Names:**

- Procedure: Erector spinae block

- Drug: Bupivacaine 0.25% Injectable Solution

- Device: Siemens Acuson x300 3-5MHz Ultrasound

**Label:** ESP group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TAP block group

**Description:** transversus abdominis block

**Name:** transversus abdominis block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- ESP group

**Description:** Erector spinae block

**Name:** Erector spinae block

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- ESP group

- TAP block group

**Description:** Local Anesthetic used in both blocks

**Name:** Bupivacaine 0.25% Injectable Solution

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- ESP group

- TAP block group

**Description:** Ultrasound used to aid in the blocks

**Name:** Siemens Acuson x300 3-5MHz Ultrasound

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Time taken to perform a successful block

**Measure:** feasibility of block

**Time Frame:** preoperative

**Description:** Time to ambulate in both groups

**Measure:** ambulation

**Time Frame:** 24 hour

**Description:** p/f ratio after first 12 , 24 hours postoperatively in both groups

**Measure:** arterial oxygen tension to fraction of inspired oxygen ratio

**Time Frame:** 12, 24 hours postoperative

**Description:** Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )

**Measure:** pulmonary complications

**Time Frame:** 12,24 hours postoperative

#### Primary Outcomes

**Description:** The analgesic efficacy of erector spinae block versus TAP block assessed by visual analogue score(range from 1 denoted the least pain to 10 as the worst pain) in 24hr in laparoscopic bariatric surgery.

**Measure:** efficacy of block

**Time Frame:** first 24 hours postoperative

#### Secondary Outcomes

**Description:** Failure rate in both groups

**Measure:** failure rate

**Time Frame:** first hour postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient age \>18 \<60
* Obese patients ; Body mass index(BMI) 40-50 kg/m2
* Both sexes
* American Society of Anesthesiologists(ASA) physical status classes II and III
* Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries

Exclusion Criteria:

* Refusal of regional block
* Patients with neurological, psychological disorders or those lacking cooperation
* Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
* Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
* Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL)
* Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
* Patients who are allergic to amide local anesthetics.
* Cases converted to open surgery will also be excluded from the study

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Faculty of Medicine

**Zip:** 11562

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.

**PMID:** 29670771

**Citation:** Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.

**PMID:** 23811424

**Citation:** Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4.

**PMID:** 29869078

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-24
