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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05188794
Other study ID # E1-21-1814
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date May 15, 2022

Study information

Verified date April 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients included in the study will be randomized into two groups (group L and group P) in the preoperative period. Following routine anesthesia induction TAP block will be applied to group L patients with the lateral approach technique, and to group P patients with the posterior approach technique. Regional block complications will be recorded. Standard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. The pain intensity of the patients will be questioned and VAS values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 15, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Procedure:
lateral tap block
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.
posterior tap block
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.

Locations

Country Name City State
Turkey Ankara City Hospital,Bilkent Ankara Cankay

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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