Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy
1 other identifier
interventional
88
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2022
CompletedApril 5, 2024
April 1, 2024
4 months
November 22, 2021
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 COMPARATORLateral transversus abdominis plane(TAP) block
Group P
ACTIVE COMPARATORPosterior transversus abdominis plane 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.
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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MİYASE SERAP DİKER, DOCTOR
ANKARA CİTY HOSPİTAL
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