Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2023-02-12

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Postoperative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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

Patients receiving right M-TAPA.

Group Type EXPERIMENTAL

Type of interfascial plane block

Intervention Type PROCEDURE

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.

Subcostal transversus abdominis plane block (subcostal TAPB) group

Patients receiving right subcostal TAPB.

Group Type EXPERIMENTAL

Type of interfascial plane block

Intervention Type PROCEDURE

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.

Interventions

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Type of interfascial plane block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No