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Bilateral Thorathic Erector Spinae Plane Block in Laparoscopic Bariatic Surgeries

ConditionPostoperative Pain Relief
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCairo University

About this trial

The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age ranges 18 to 60 years old

Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2

American Society of Anesthesiologists (13) physical status classes II to III

Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries

Disqualifiers

• Refusal of regional block

Patients with neurological, psychological disorders or those lacking cooperation.

Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea.

Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.

Trial population

included Patient age will range 18 to 60 years, Body mass index(BMI) ≥ 35 - 50 kg/m2, American Society of Anesthesiologists physical status classes II to III, scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries, with normal coagulation profile, npt allergic to amide

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • one level ESPB

    Procedure/Surgery

    Ultrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae

  • two level ESPB

    Procedure/Surgery

    The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra)(19) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae). The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: One level ESPB1 intervention
Group B: two level ESPB1 intervention

Trial outcomes

Primary outcomes

1

• Comparison of mean visual analog scale scores at 24 hours postoperative between study groups

Time frame
24 hours

Secondary outcomes

1

Time for first rescue analgesia in both groups

Time frame
24 hours
2

b) Total opioid consumption in both groups in 24hr postoperative

Time frame
24 hours
3

Failure rate in performing the block

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: