Comparison of ESP Block and STAP Plane Block

NCT ID: NCT06663449

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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regional anesthesia Erector spinae plane block subcostal transversus abdominis plane block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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GROUP USING subcostal transversus abdominis plane block

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.

Group Type ACTIVE_COMPARATOR

subcostal transversus abdominis plane block

Intervention Type PROCEDURE

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

GROUP USING erector spinae plane block

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.

Group Type ACTIVE_COMPARATOR

erector spinae plane block

Intervention Type PROCEDURE

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

Interventions

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subcostal transversus abdominis plane block

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

Intervention Type PROCEDURE

erector spinae plane block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Sevim Cesur

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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sevim Cesur Okan

Role: CONTACT

Phone: 0 541 911 41 00

Email: [email protected]

Facility Contacts

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Sevim Cesur, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 25250301 (View on PubMed)

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.

Reference Type RESULT
PMID: 23493523 (View on PubMed)

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.

Reference Type RESULT
PMID: 29785136 (View on PubMed)

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.

Reference Type RESULT
PMID: 34661682 (View on PubMed)

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.

Reference Type RESULT
PMID: 31205117 (View on PubMed)

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.

Reference Type RESULT
PMID: 29670771 (View on PubMed)

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

Reference Type RESULT
PMID: 16334492 (View on PubMed)

Other Identifiers

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KAEK/13.bI.04

Identifier Type: -

Identifier Source: org_study_id