NCT06660966

Brief Summary

After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. MTAPA has been defined as a technique that is performed in the supine position and is easier to apply than the other mentioned blocks. In our study, we aimed to investigate the effectiveness of this block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

laparoscopic cholecystectomyMTAPA blockESP blockpostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    Numerical pain score below 3

    postoperative 24 hours

Study Arms (2)

Group M

ACTIVE COMPARATOR

M TAPA applied group

Procedure: M TAPA block

Group E

ACTIVE COMPARATOR

ESB applied Group

Procedure: ESP block group

Interventions

M TAPA blockPROCEDURE

Grup M: The patients who underwent M-TAPA block were placed in the supine position. The right upper quadrant of the abdomen was cleaned with antiseptic solution. For the block procedure, 20-30 ml of 0.25% bupivacaine, 22G 8.5 cm stimuplex needle and 10-14 Hz high frequency USG were prepared for the procedure. The USG probe was determined in the costochondral area at the mid-clavicular line, and the internal and transversus abdominis muscles were determined. The needle was advanced with the in plane technique from cephalad to caudal, passing through the skin, subcutaneous, external and internal oblique muscles, respectively, and then over the transversus abdominis fascia. After the target was confirmed with 2 ml of saline, 0.3 mg / kg bupivacaine (20-30 ml) was administered.

Group M

In Group E, patients who were to undergo ESP block were placed in the lateral position with the right side up. The T8-T10 dorsal region was cleaned appropriately with antiseptic solution. For the block procedure, 20-30cc %0.25 bupivacaine, 22G 8.5cm stimuplex needle and 10-14Hz high frequency USG were prepared for the procedure. The USG probe is first determined in the sagittal direction, the spinous process of the T10 thoracic vertebra is then followed 1-2 cm above the transverse process, with the in plane technique, the skin, subcutaneous tissue and erector spina muscle are passed, the needle is touched to the transverse process and the target is confirmed with 2cc saline, then 20-30 cc (0.5 mg / kg bupivacaine) of local anesthetic is administered and the procedure is terminated.

Group E

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gaziantep

Şehitkamil, Gaziantep, 27031, Turkey (Türkiye)

Location

Related Publications (3)

  • Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The successful usage of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for analgesia of laparoscopic ventral hernia repair. J Clin Anesth. 2019 Nov;57:1-2. doi: 10.1016/j.jclinane.2019.02.016. Epub 2019 Mar 1. No abstract available.

    PMID: 30831469BACKGROUND
  • Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.

    PMID: 31212124BACKGROUND
  • Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.

    PMID: 36307755BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Prof. Dr

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

August 15, 2023

Primary Completion

January 15, 2024

Study Completion

May 15, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations