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Not yet recruiting NCT06663449

Comparison of ESP Block and STAP Plane Block

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: subcostal transversus abdominis plane block, erector spinae plane block.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of ESP Block and STAP Plane Block in Laparoscopic Cholecystectomy Surgery

Overview

In order to effectively manage postoperative analgesia in patients planned to undergo elective laparoscopic cholecystectomy, patients will be divided into 2 (two) groups and informed consent forms will be obtained after the necessary information is provided so that both groups can be included in the study. In the group planned to undergo erector spinae plane block, erector spinae plane block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. In patients who will undergo subcostal transversus abdominis plane block, subcostal tap block will be performed after monitoring and sedation in the operating room block unit before being taken to the surgical table preoperatively and postoperative PCA analgesia will be applied. The patients' perioperative pain will be monitored with NOL (nociception level) monitor. Remifentanil dose will be adjusted to keep the NOL level between 10 and 25. After the patients are followed up for 24 hours postoperatively, their additional analgesia needs and amounts during this process will be compared. In this way, it is aimed to show that the analgesic method can be used effectively in the follow-up of pain management by comparing the Erector Spina Plane block and the Subcostal Transversus Abdominis Plane block as an effective analgesic application in laparoscopic cholecystectomy operations.

Interventions

  • Procedure subcostal transversus abdominis plane block
    subcostal transversus abdominis plane block will be performed using 20 mL of 0.25 bupivacaine
  • Procedure erector spinae plane block
    erector spinae plane block will be performed using 20 mL of 0.25 bupivacaine

Primary outcome measures

  • NRS Scores [Time frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)]
  • Morphine consumption [Time frame: 1 hours after surgery(T1), 3 hours after surgery (T2), 6 hours after surgery (T3), 12 hours after surgery (T4) and 24 hours after surgery(T5)]

Eligibility criteria

Inclusion criteria

  • Patients who will undergo laparoscopic cholecystectomy:
  • 18-75 years old
  • ASA I-II-III patients

Exclusion criteria

  • Use of anticoagulant drugs
  • Known allergy to drugs to be used
  • Infection in the area where the block will be performed
  • Patient's reluctance

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Kocaeli University — Kocaeli

Publications

  • Hashemi SJ, Heydari SM, Hashemi ST. Paravertebral block using bupivacaine with/without fentanyl on postoperative pain after laparoscopic cholecystectomy: A double-blind, randomized, control trial. Adv Biomed Res. 2014 Sep 4;3:187. doi: 10.4103/2277-9175.140099. eCollection 2014. PMID 25250301
  • Agarwal A, Batra RK, Chhabra A, Subramaniam R, Misra MC. The evaluation of efficacy and safety of paravertebral block for perioperative analgesia in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2012 Oct-Dec;6(4):344-9. doi: 10.4103/1658-354X.105860. PMID 23493523
  • Mimic A, Bantel C, Jovicic J, Mimic B, Kisic-Tepavcevic D, Durutovic O, Ladjevic N. Psychological factors as predictors of early postoperative pain after open nephrectomy. J Pain Res. 2018 May 9;11:955-966. doi: 10.2147/JPR.S152282. eCollection 2018. PMID 29785136
  • Vrsajkov V, Ilic N, Uvelin A, Ilic R, Lukic-Sarkanovic M, Plecas-Duric A. Erector spinae plane block reduces pain after laparoscopic cholecystectomy. Anaesthesist. 2021 Dec;70(Suppl 1):48-52. doi: 10.1007/s00101-021-01015-5. Epub 2021 Oct 18. PMID 34661682
  • Kim S, Bang S, Kwon W. Intermittent erector spinae plane block as a part of multimodal analgesia after open nephrectomy. Chin Med J (Engl). 2019 Jun 20;132(12):1507-1508. doi: 10.1097/CM9.0000000000000269. No abstract available. PMID 31205117
  • Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018. PMID 29670771
  • Grass JA. Patient-controlled analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S44-S61. doi: 10.1213/01.ANE.0000177102.11682.20. PMID 16334492

Identifiers

NCT: NCT06663449 · KAEK/13.bI.04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗