- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06845215
Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty
Introduction: Abdominoplasty involves the removal of excess skin and fat from the abdominal region, rectus sheath plication, and umbilical transposition. The number of cosmetic abdominoplasty procedures has been steadily increasing in recent years. Due to extensive tissue manipulation and large incisions during surgery, postoperative pain has become a significant concern. Studies report that up to 80% of patients experience postoperative pain; however, fewer than half of these patients receive adequate analgesia. Improving postoperative pain control has been shown to facilitate early mobilization, reduce hospital length of stay, lower healthcare costs, and enhance patient satisfaction. Therefore, ensuring effective postoperative analgesia has become a critical aspect of patient management.
Transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are peripheral nerve block techniques that can be used as part of a multimodal analgesia approach for postoperative pain management after abdominoplasty. In this study, we aimed to compare the effects of TAP and ESP blocks on postoperative pain in patients undergoing abdominoplasty.
Aim/Hypothesis:
H0: There is a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty.
H1: There is not a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty.
Materials and Methods: Our study was designed as a retrospective analysis. Patient records and hospital database will be reviewed to identify all patients who underwent abdominoplasty and received TAP block or ESP block for postoperative analgesia. Demographic data including age, gender, weight, height, body mass index (BMI) and American Society of Anesthesiologists (ASA) classification, as well as comorbidities and medications used will be recorded on case report forms. The type of block performed (TAP or ESP) and postoperative pain scores obtained from pain assessment forms using the Numerical Rating Scale (NRS) at 0, 2, 4, 6, 12 and 24 hours postoperatively will be documented. In addition, data from the patient-controlled analgesia (PCA) device will be recorded, including number of doses demanded (DEM) and number of doses delivered (DEL). Other parameters such as additional analgesic requirements, postoperative nausea and vomiting, itching and patient satisfaction will also be recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erbil Türksal, Specialist
- Phone Number: +90 530 228 1319
- Email: drerbilturksal@hotmail.com
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey, 06290
- Recruiting
- University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
-
Contact:
- Erbil Türksal, Specialist
- Phone Number: +90 530 228 1319
- Email: drerbilturksal@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent abdominoplasty and received TAP or ESP blocks for postoperative analgesia, followed by monitoring with IV PCA.
Exclusion Criteria:
- Cases in which IV PCA was not used, VAS scoring was unavailable, or complications occurred.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients who underwent abdominoplasty and received TAP block
Patients who underwent abdominoplasty and received TAP block for postoperative analgesia, followed by intravenous patient-controlled analgesia (IV PCA).
|
Ultrasound-guided TAP block
|
|
Patients who underwent abdominoplasty and received ESP block
Patients who underwent abdominoplasty and received ESP block for postoperative analgesia, followed by intravenous patient-controlled analgesia (IV PCA).
|
Ultrasound-guided ESP block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: Postoperative 24 hours
|
Visual Analogue Scale (VAS).
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
|
Postoperative 24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Erbil Türksal, Specialist, University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-KAEK-15/2619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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