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Completed

NCT Number: NCT03747406

Erector Spinae Block and Transverse Abdominis Plane Block for 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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine - Cairo University

Cairo, Egypt

About this study

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

  • 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.
  • 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.
  • Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
  • Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Cumulative opioid consumption during the first 24 h postoperatively

    Time frame: 24 hours after surgery

    measure total opioid dose in 24 hours after surgery

Secondary outcomes

  1. pain assessment by Visual Analog Scale

    Time frame: 24 hours after surgery

    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

Sponsors and collaborators

Lead sponsor

Dalia Ismail

Other

Collaborators

  • Abdelhamid, Bassant Mohamed, M.D.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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