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Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ultrasound guided subcostal transversus abdominis plane block (TAPB)

Ropivacaine 0.75% Injectable Solution

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

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Stomach neoplasms, Nerve block

Eligibility Criteria

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

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group T

Group C

Arm Description

Patients receiving bilateral subcostal TAP block.

Patients not receiving bilateral subcostal TAP block.

Outcomes

Primary Outcome Measures

Total fentanyl consumption during 24 hours

postoperative cumulative fentanyl consumption (mcg)

Secondary Outcome Measures

Total fentanyl consumption

postoperative cumulative fentanyl consumption (mcg)

Postoperative pain score

11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

occurrence of opioid-related side effects

Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

Rescue nonopioid(ketorolac, nefopam) analgesic requirement

Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement

Full Information

NCT ID

NCT04138901

First Posted

October 23, 2019

Last Updated

August 11, 2020

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04138901

Brief Title

Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Official Title

Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

May 30, 2020 (Actual)

Study Completion Date

June 7, 2020 (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 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.

Detailed Description

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.

6. Conditions and Keywords

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

Postoperative Pain

Keywords

Postoperative pain, Stomach neoplasms, Nerve block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective randomized double-blinded study

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group T

Arm Type

Experimental

Arm Description

Patients receiving bilateral subcostal TAP block.

Arm Title

Group C

Arm Type

No Intervention

Arm Description

Patients not receiving bilateral subcostal TAP block.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound guided subcostal transversus abdominis plane block (TAPB)

Other Intervention Name(s)

TAP block

Intervention Description

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

Drug

Intervention Name(s)

Ropivacaine 0.75% Injectable Solution

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Total fentanyl consumption during 24 hours

Description

postoperative cumulative fentanyl consumption (mcg)

Time Frame

postoperative 24 hours

Secondary Outcome Measure Information:

Title

Total fentanyl consumption

Description

postoperative cumulative fentanyl consumption (mcg)

Time Frame

postoperative 6, 12, 48 hours

Title

Postoperative pain score

Description

11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

Time Frame

postoperative 6, 12, 24, 48 hours

Title

occurrence of opioid-related side effects

Description

Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

Time Frame

postoperative 6, 12, 24, 48 hours

Title

Rescue nonopioid(ketorolac, nefopam) analgesic requirement

Description

Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement

Time Frame

postoperative 6, 12, 24, 48 hours

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hojin Lee, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

KS013

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

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