Compares two nerve block approaches for pain after weight-loss surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for obese adults having laparoscopic weight-loss surgery. It compares a nerve block at one level of the back with a block at two levels, for pain relief.

Age

18 to 60 years

Sex

Women and men can join.

Disease stage

Obesity with a body mass index (BMI) of 35 to 50 kg/m2. Health status class II to III (American Society of Anesthesiologists). Planned laparoscopic sleeve gastrectomy and/or Roux-en-Y gastric bypass surgery.

Earlier treatment

People with a history of previous bariatric (weight-loss) surgery cannot join.

Main reasons for not taking part

• Refusing the regional nerve block
• Nerve or mental health disorders, or being unable to cooperate
• Surgery planned together with gallbladder removal or paraumbilical hernia repair, previous weight-loss surgery, or obstructive sleep apnea
• Skin wounds or body shape differences where the needle goes in
• Bleeding disorders, liver disease, or allergy to amide local anesthetics

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 60 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• One level ESPB

  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

  The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra) 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