Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

NCT03747406 | Completed

• 1 other identifier: N-125-2018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption during the first 24 h postoperatively

  measure total opioid dose in 24 hours after surgery

  24 hours after surgery

Secondary Outcomes (1)

• pain assessment by Visual Analog Scale

  24 hours after surgery

Study Arms (3)

ESP group

EXPERIMENTAL

The patient rolled to his side, the level between T9 and T10 identified using ultrasound. An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced inplane until contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration confirmed. The same procedure will be repeated in the contralateral side.

Procedure: Erector spinae plane block

TAP group

EXPERIMENTAL

The patient in supine position. Under complete aseptic conditions, a linear array transducer 5-12 MHz (Siemens ACUSON X300 Ultrasound System) will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers.

Procedure: TAP block

opioid group

NO INTERVENTION

will receive intravenous morphine with general anesthesia and total opioid consumption will be calculated

Interventions

Erector spinae plane block PROCEDURE

the level between T9 and T10 will be identified using ultrasound as well as transverse processes depth. An array probe will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge Tuohy needle will be advanced inplane until it made contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration was confirmed. The same procedure will be repeated in the contralateral side.

ESP group

TAP block PROCEDURE

a linear array transducer 5-12 MHz will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge needle will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers.

TAP group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients from 18 to 59 years.
• BMI \> 40 kg/m2
• Genders eligible for study: both.
• ASA I-III.
• No contraindications for application of regional anesthesia as Patient refusal, local anesthetic allergy, local sepsis or infection at puncture site, INR \> 1.5 or \< 12 hours post LMWH.

You may not qualify if:

• Patient refusal.
• Extremes of age.
• ASA IV.
• Increased intracranial pressure.
• Coagulopathy or thrombocytopenia less than 100000/ml.
• Sepsis (increased risk of meningitis).
• Infection at the puncture site.
• Pre-existing neurologic disease.
• History of allergy to local anesthetic.

Sponsors & Collaborators

• Dalia Ismail: lead
• Abdelhamid, Bassant Mohamed, M.D.: collaborator

Study Sites (1)

Faculty of Medicine - Cairo University

Cairo, Egypt

Location

Study Officials

• Bassant M Abdelhamid, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dalia Khaled, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Anaesthesia- Cairo University

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 10, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)