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Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain, Acute

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Type of interfascial plane block

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute focused on measuring cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

Subcostal transversus abdominis plane block (subcostal TAPB) group

Arm Description

Patients receiving right M-TAPA.

Patients receiving right subcostal TAPB.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain score at rest

Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting

Postoperative pain score during coughing

Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing

Patient satisfaction before discharge

Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction)

Occurrence rate of postoperative nausea, vomiting

Incidence of postoperative nausea and vomiting (%)

Full Information

NCT ID

NCT05207306

First Posted

January 2, 2022

Last Updated

August 20, 2023

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05207306

Brief Title

Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

Official Title

Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 5, 2022 (Actual)

Primary Completion Date

February 12, 2023 (Actual)

Study Completion Date

February 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Acute

Keywords

cholecystectomy, thoracoabdominal nerves block, transversus abdominis plane block, interfascial plane block, regional analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective randomized controlled trial

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Patients receiving right M-TAPA.

Arm Title

Subcostal transversus abdominis plane block (subcostal TAPB) group

Arm Type

Experimental

Arm Description

Patients receiving right subcostal TAPB.

Intervention Type

Procedure

Intervention Name(s)

Type of interfascial plane block

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum postoperative pain score during 12hours postoperatively

Description

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

Time Frame

at 12hour postoperatively.

Secondary Outcome Measure Information:

Title

Postoperative pain score at rest

Description

Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting

Time Frame

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

Title

Postoperative pain score during coughing

Description

Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing

Time Frame

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

Title

Patient satisfaction before discharge

Description

Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction)

Time Frame

at immediately before discharge

Title

Occurrence rate of postoperative nausea, vomiting

Description

Incidence of postoperative nausea and vomiting (%)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled to undergo elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical classification I-II Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hojin Lee, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

Please Select An Option

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

31212124

Citation

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.

Results Reference

background

PubMed Identifier

31176261

Citation

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.

Results Reference

background

PubMed Identifier

22967210

Citation

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.

Results Reference

background

PubMed Identifier

27687350

Citation

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.

Results Reference

background

PubMed Identifier

30396100

Citation

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.

Results Reference

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Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

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