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Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

Primary Purpose

Analgesia, Patient-Controlled, Postoperative Pain, Acute

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

lateral tap block

posterior tap block

About this trial

This is an interventional supportive care trial for Analgesia, Patient-Controlled

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASAI-III patients undergoing laparoscopic nephrectomy
18<BMI<40

Exclusion Criteria:

infection at the block site
coagulation disorder
pregnancy
kidney failure
liver failure
heart failure
allergy to local anesthetics
patient refusal

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group L

Group P

Arm Description

Lateral transversus abdominis plane(TAP) block

Posterior transversus abdominis plane block

Outcomes

Primary Outcome Measures

Visual analog pain scale 0

Visual analog pain scale 1

Visual Analog Pain scale 2

Visual analog pain scale 6

Visual Analog Pain scale 12

Visual Analog Pain scale 18

Visual Analog Pain scale 24

opioid comsuption

Secondary Outcome Measures

Full Information

NCT ID

NCT05188794

First Posted

November 22, 2021

Last Updated

December 27, 2021

Sponsor

Ankara City Hospital Bilkent

1. Study Identification

Unique Protocol Identification Number

NCT05188794

Brief Title

Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

Official Title

Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2022 (Anticipated)

Primary Completion Date

May 1, 2022 (Anticipated)

Study Completion Date

May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Secondary aim is to compare complication rates of the two techniques.

6. Conditions and Keywords

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

Analgesia, Patient-Controlled, Postoperative Pain, Acute

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group L

Arm Type

Active Comparator

Arm Description

Lateral transversus abdominis plane(TAP) block

Arm Title

Group P

Arm Type

Active Comparator

Arm Description

Posterior transversus abdominis plane block

Intervention Type

Procedure

Intervention Name(s)

lateral tap block

Intervention Description

In the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.

Intervention Type

Procedure

Intervention Name(s)

posterior tap block

Intervention Description

In the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.

Primary Outcome Measure Information:

Title

Visual analog pain scale 0

Time Frame

at the PACU arrival

Title

Visual analog pain scale 1

Time Frame

Postoperative first hour

Title

Visual Analog Pain scale 2

Time Frame

Postoperative second hour

Title

Visual analog pain scale 6

Time Frame

Postoperative sixth hour

Title

Visual Analog Pain scale 12

Time Frame

Postoperative 12. hour

Title

Visual Analog Pain scale 18

Time Frame

Postoperative18. hour

Title

Visual Analog Pain scale 24

Time Frame

Postoperative 24. hour

Title

opioid comsuption

Time Frame

Within 24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASAI-III patients undergoing laparoscopic nephrectomy 18<BMI<40 Exclusion Criteria: infection at the block site coagulation disorder pregnancy kidney failure liver failure heart failure allergy to local anesthetics patient refusal

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MİYASE SERAP DİKER, DOCTOR

Phone

+905325730308

serap.diker@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

AYSE SEMA TÜRKAY YILMAZ, DOCTOR

Phone

+905065951466

dr.ayseturkay@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MİYASE SERAP DİKER, DOCTOR

Organizational Affiliation

ANKARA CİTY HOSPİTAL

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

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