NCT04138901

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2019

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

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

October 23, 2019

Last Update Submit

August 11, 2020

Conditions

Postoperative Pain

Keywords

Postoperative painStomach neoplasmsNerve block

Outcome Measures

Primary Outcomes (1)

  • Total fentanyl consumption during 24 hours

    postoperative cumulative fentanyl consumption (mcg)

    postoperative 24 hours

Secondary Outcomes (4)

  • Total fentanyl consumption

    postoperative 6, 12, 48 hours

  • Postoperative pain score

    postoperative 6, 12, 24, 48 hours

  • occurrence of opioid-related side effects

    postoperative 6, 12, 24, 48 hours

  • Rescue nonopioid(ketorolac, nefopam) analgesic requirement

    postoperative 6, 12, 24, 48 hours

Study Arms (2)

Group T

EXPERIMENTAL

Patients receiving bilateral subcostal TAP block.

Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB)Drug: Ropivacaine 0.75% Injectable SolutionDevice: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

Group C

NO INTERVENTION

Patients not receiving bilateral subcostal TAP block.

Interventions

Ultrasound guided subcostal transversus abdominis plane block (TAPB)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.

Also known as: TAP block
Group T
Ropivacaine 0.75% Injectable SolutionDRUG

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

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

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

Group T

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Pain, PostoperativeStomach Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Hojin Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized double-blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

November 4, 2019

Primary Completion

May 30, 2020

Study Completion

June 7, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)