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NCT06377605Befejeződött

The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients.

The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 21.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. [1] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing [2]. Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential [14]. Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia [3]. ESPB is effective, easy to perform, and can be performed in a short time. [4] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery [5]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity. Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. [15] Few studies examined the use of ESPB in bariatric surgery [3,6,7], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient. So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
60 (tényleges)
Első benyújtás
2024. ápr. 17.
Kezdés
2024. márc. 10.
Elsődleges befejezés
2025. máj. 30.
Fő szponzor
Amany Ahmed Eissa
Betegségek
Elhízás
NCT-szám
NCT06377605

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 60
  • 2024. márc. 10. és az elsődleges befejezés (2025. máj. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Laborértékek

  • • 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.
    • Patients with bleeding disorders defined as (INR >1.4) and/ or (platelet count <100,000/µL)
    • Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
    • Patients who are allergic to amide local anesthetics.
    • Cases converted to open surgery will also be excluded from the study

Kiket keres a vizsgálat

  • Patient age >18 <60
    • Super Obese patients ; Body mass index(BMI) > 50 kg/m2
    • Both sexes
    • American Society of Anesthesiologists(ASA) physical status classes II and III
    • Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries

Életkor a regiszterben: 18 év – 60 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Kasr Al Ainy HospitalsCairoEgyiptomIsmeretlen állapot

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