Clinical trial NCT03747406: Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy
Official title: Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Abdelhamid, Bassant Mohamed, M.D.
First posted: 2018-11-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative opioid consumption during the first 24 h postoperatively
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: pain assessment by Visual Analog Scale
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine - Cairo University
Study officials:
affiliation: Cairo University
name: Bassant M Abdelhamid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dalia Khaled, MD
role: STUDY_DIRECTOR
References: