NCT05188794

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

November 22, 2021

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Visual analog pain scale 0

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    at the PACU arrival

  • Visual analog pain scale 1

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative first hour

  • Visual Analog Pain scale 2

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative second hour

  • Visual analog pain scale 6

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative sixth hour

  • Visual Analog Pain scale 12

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative 12. hour

  • Visual Analog Pain scale 18

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative18. hour

  • Visual Analog Pain scale 24

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Postoperative 24. hour

  • opioid comsuption

    Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

    Within 24 hours postoperatively

Study Arms (2)

group L

ACTIVE COMPARATOR

Lateral transversus abdominis plane(TAP) block

Procedure: lateral tap block

Group P

ACTIVE COMPARATOR

Posterior transversus abdominis plane block

Procedure: posterior tap block

Interventions

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.

group L

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.

Group P

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASAI-III patients undergoing laparoscopic nephrectomy
  • \<BMI\<40

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital,Bilkent

Ankara, Cankay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • MİYASE SERAP DİKER, DOCTOR

    ANKARA CİTY HOSPİTAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaestesia and Reanimation Specialist

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 12, 2022

Study Start

January 1, 2022

Primary Completion

May 1, 2022

Study Completion

May 15, 2022

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations