Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-06-07

Brief Summary

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This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

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Detailed Description

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Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective randomized double-blinded study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.

Study Groups

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Group T

Patients receiving bilateral subcostal TAP block.

Group Type EXPERIMENTAL

Ultrasound guided subcostal transversus abdominis plane block (TAPB)

Intervention Type PROCEDURE

At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.

Ropivacaine 0.75% Injectable Solution

Intervention Type DRUG

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Intervention Type DEVICE

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Group C

Patients not receiving bilateral subcostal TAP block.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound guided subcostal transversus abdominis plane block (TAPB)

At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.

Intervention Type PROCEDURE

Ropivacaine 0.75% Injectable Solution

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Intervention Type DRUG

21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Intervention Type DEVICE

Other Intervention Names

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TAP block

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-III
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria

* Do not understand our study
* Allergies to anesthetic or analgesic medications
* Wound infiltration analgesia for postoperative pain control
* Infection or anatomic abnormality at the needle insertion site
* Pregnancy/Breast feeder
* Medical or psychological disease that can affect the treatment response

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No