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CompletedNCT03747406Updated Dec 26, 2019

Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

An interventional study of Erector spinae plane block and TAP block in Bariatric Surgery Candidate, sponsored by Dalia Ismail. Completed at 1 site in Egypt. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-26.

Sponsored by Dalia Ismail · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Bariatric Surgery Candidate
03

In context

Lead sponsor

This is the only study on the registry with Dalia Ismail as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
66 participants (actual)

Study arms

  • 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

  • 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

  • No intervention
    opioid group

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

Interventions

  • ProcedureErector 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.

  • ProcedureTAP 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.

06

What researchers measure

Primary outcomes

  1. Cumulative opioid consumption during the first 24 h postoperatively

    measure total opioid dose in 24 hours after surgery

    Time frame: 24 hours after surgery

Secondary outcomes

  1. 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

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Faculty of Medicine - Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03747406
Lead sponsor
Dalia Ismail
Collaborators
Abdelhamid, Bassant Mohamed, M.D.
Responsible party
Dalia Ismail (Lecturer of Anaesthesia- Cairo University, Cairo University) — Sponsor-investigator
First posted
Nov 20, 2018
Start date
Dec 1, 2018
Primary completion
Jun 1, 2019
Completion
Jul 10, 2019
Last update
Dec 26, 2019

Study contacts

Bassant M Abdelhamid, MD
principal investigator · Cairo University
Dalia Khaled, MD
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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