- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06566859
Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases
August 20, 2024 updated by: Hilal AKCA, Başakşehir Çam & Sakura City Hospital
Relieving postoperative nephrectomy pain requires multimodal approaches.
Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics.
This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Relieving postoperative nephrectomy pain requires multimodal approaches.
The most commonly used in the treatment of pain are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and infiltration of local anesthetics.
Due to the side effects of NSAIDs and opioids, the application of regional analgesia techniques can reduce complications while providing better analgesia quality.
Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics.
Pain is considered one of the most important factors affecting the quality of healing.
Postoperative pain delays the postanesthesia care unit, hospital stay, early ambulation, increases resource utilization, and negatively affects patient satisfaction.
If postoperative analgesia is provided, all these negativities will be eliminated.
This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hilal Akça
- Phone Number: 05548421509
- Email: drhllbs@gmail.com
Study Locations
-
-
-
Istanbul, Turkey
- BasaksehirCamSakuraH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy.
.
Description
Inclusion Criteria:
- All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy
Exclusion Criteria:
- ASA ≥3
- Body mass index>35 kg/ m²
- Infection in the block area
- Coagulation disorder,
- Known allergy to local anesthetics
- Pregnant
- Patient with neuropathy
- Patient without cooperation
- Patient who refuses to participate in the study
- Patients under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
M-TAPA Block
Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and M-TAPA block is applied under ultrasound guidance in the preoperative period.
For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.
|
Numerical rating scala
Numerical rating scala
Numerical rating scala
Numerical rating scala
|
|
ESP Block
Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and ESP block is applied under ultrasound guidance in the preoperative period.
For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.
|
Numerical rating scala
Numerical rating scala
Numerical rating scala
Numerical rating scala
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Management
Time Frame: 0.hour
|
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS.
NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity.
The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
|
0.hour
|
|
Postoperative Pain Management
Time Frame: 6.hour
|
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS.
NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity.
The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
|
6.hour
|
|
Postoperative Pain Management
Time Frame: 12.hour
|
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS.
NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity.
The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
|
12.hour
|
|
Postoperative Pain Management
Time Frame: 24.hour
|
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS.
NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity.
The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
|
24.hour
|
|
Postoperative Pain Management
Time Frame: 24 hours
|
Total amount of analgesic used in 24 hours
|
24 hours
|
|
Postoperative Pain Management
Time Frame: 24 hours
|
Time of first additional analgesic requirement up to 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hilal Akça, BasaksehirCamSakuraH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
August 11, 2024
First Submitted That Met QC Criteria
August 20, 2024
First Posted (Actual)
August 22, 2024
Study Record Updates
Last Update Posted (Actual)
August 22, 2024
Last Update Submitted That Met QC Criteria
August 20, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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