NCT05207306

Brief Summary

This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).

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 Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

January 2, 2022

Last Update Submit

August 20, 2023

Conditions

Postoperative Pain, Acute

Keywords

cholecystectomythoracoabdominal nerves blocktransversus abdominis plane blockinterfascial plane blockregional analgesia

Outcome Measures

Primary Outcomes (1)

  • Maximum postoperative pain score during 12hours postoperatively

    maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively

    at 12hour postoperatively.

Secondary Outcomes (4)

  • Postoperative pain score at rest

    at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge

  • Postoperative pain score during coughing

    at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge

  • Patient satisfaction before discharge

    at immediately before discharge

  • Occurrence rate of postoperative nausea, vomiting

    at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.

Study Arms (2)

Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) group

EXPERIMENTAL

Patients receiving right M-TAPA.

Procedure: Type of interfascial plane block

Subcostal transversus abdominis plane block (subcostal TAPB) group

EXPERIMENTAL

Patients receiving right subcostal TAPB.

Procedure: Type of interfascial plane block

Interventions

Type of interfascial plane blockPROCEDURE

In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.

Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) groupSubcostal transversus abdominis plane block (subcostal TAPB) group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical classification I-II

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical classification III or more
  • Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
  • Allergies to anesthetic or analgesic medications used in the protocol
  • Single port laparoscopic cholecystectomy
  • Patients with infection at the abdominal wall
  • Medical or psychological disease that can affect the treatment response
  • Do not understand our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Please Select An Option, 03080, South Korea

Location

Related Publications (5)

  • 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

  • Ueshima H, Hiroshi O. RETRACTED: Thoracoabdominal nerves block through the perichondral approach for effective perioperative analgesia during upper abdominal surgery. J Clin Anesth. 2020 Feb;59:7. doi: 10.1016/j.jclinane.2019.06.008. Epub 2019 Jun 5. No abstract available.

    PMID: 31176261BACKGROUND

  • Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.

    PMID: 22967210BACKGROUND

  • Oksar M, Koyuncu O, Turhanoglu S, Temiz M, Oran MC. Transversus abdominis plane block as a component of multimodal analgesia for laparoscopic cholecystectomy. J Clin Anesth. 2016 Nov;34:72-8. doi: 10.1016/j.jclinane.2016.03.033. Epub 2016 May 2.

    PMID: 27687350BACKGROUND

  • Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.

    PMID: 30396100BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hojin Lee, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were blinded to the allocation, because that investigator performed nerve block after induction of anesthesia. The outcome assessor not involved in this study will investigate the outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant clinical professor

Study Record Dates

First Submitted

January 2, 2022

First Posted

January 26, 2022

Study Start

April 5, 2022

Primary Completion

February 12, 2023

Study Completion

February 12, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

KR(1)