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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: NRS 0. hour
Numerical rating scala
Other: NRS 6. Hour
Numerical rating scala
Other: NRS 12. Hour
Numerical rating scala
Other: NRS 24. Hour
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.
Other: NRS 0. hour
Numerical rating scala
Other: NRS 6. Hour
Numerical rating scala
Other: NRS 12. Hour
Numerical rating scala
Other: NRS 24. Hour
Numerical rating scala

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Başakşehir Çam & Sakura City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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