Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: TAP block

Detailed Description

Primary outcomes

• Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.

Secondary outcome parameters

1. Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.
2. Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
3. Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
4. Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP group; 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; 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.
Experimental: TAP group; 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; 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.
No Intervention: opioid group; will receive intravenous morphine with general anesthesia and total opioid consumption will be calculated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative opioid consumption during the first 24 h postoperatively	measure total opioid dose in 24 hours after surgery	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment by Visual Analog Scale	it is a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.If the VAS level is 5 or more this means failure of analgesio and a dose of rescue analgesia is given	24 hours after surgery

Collaborators and Investigators

• Sponsor: Dalia Ismail
• Collaborators: Abdelhamid, Bassant Mohamed, M.D.
• Investigators: Principal Investigator: Bassant M Abdelhamid, MD, Cairo University; Study Director: Dalia Khaled, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 17, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-125-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No