Comparison of ESP Block and STAP Plane Block

NCT06663449 | Not Yet Recruiting

• 1 other identifier: KAEK/13.bI.04
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

regional anesthesia; Erector spinae plane block; subcostal transversus abdominis plane block

Outcome Measures

Primary Outcomes (2)

• NRS Scores

  NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)

  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

  Amount of morphine consumption (mg)

  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)

Study Arms (2)

GROUP USING subcostal transversus abdominis plane block

ACTIVE COMPARATOR

Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then subcostal tap block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The 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 period will be compared.

Procedure: subcostal transversus abdominis plane block

GROUP USING erector spinae plane block

ACTIVE COMPARATOR

Before being taken to the surgical table preoperatively, monitoring and sedation will be performed in the operating room block unit, then erector spinae plane block will be performed and postoperative PCA will be applied.Patients' perioperative pain will be monitored with a NOL (nociception level) monitor. The 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 period will be compared.

Procedure: erector spinae plane block

Interventions

subcostal transversus abdominis plane block PROCEDURE

subcostal transversus abdominis plane block will be performed using 20 mL of 0.25 bupivacaine

GROUP USING subcostal transversus abdominis plane block

erector spinae plane block PROCEDURE

erector spinae plane block will be performed using 20 mL of 0.25 bupivacaine

GROUP USING erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Grass JA. Patient-controlled analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S44-S61. doi: 10.1213/01.ANE.0000177102.11682.20.

  PMID: 16334492 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

sevim Cesur Okan

CONTACT

0 541 911 41 00; svmcsr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 29, 2024
• Study Start: December 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

TU (1)