Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747406
• Other study ID #: N-125-2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: July 10, 2019

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 10, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine - Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Dalia Ismail	Abdelhamid, Bassant Mohamed, M.D.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption during the first 24 h postoperatively	measure total opioid dose in 24 hours after surgery	24 hours after surgery
Secondary	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