NCT06845215

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

June 15, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

June 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    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

Study Arms (2)

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).

Procedure: Transversus abdominis plane (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).

Procedure: Erector spina plane block (ESP)

Interventions

Ultrasound-guided TAP block

Patients who underwent abdominoplasty and received TAP block

Ultrasound-guided ESP block

Patients who underwent abdominoplasty and received ESP block

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent abdominoplasty in our hospital between July 2018 and July 2023 and met the inclusion criteria.

You may qualify if:

  • Patients who underwent abdominoplasty and received TAP or ESP blocks for postoperative analgesia, followed by monitoring with IV PCA.

You may not qualify if:

  • Cases in which IV PCA was not used, VAS scoring was unavailable, or complications occurred.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeBites and Stings

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Erbil Türksal, Specialist

    University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ERBİL TÜRKSAL, Specialist

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

February 20, 2025

Primary Completion

June 20, 2025

Study Completion

July 20, 2025

Last Updated

June 15, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations