Clinical Trials Logo

Clinical Trial Summary

Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction.

The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.

The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle.

In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.


Clinical Trial Description

Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 15.0.5 for windows (2017) using previous results with the mean opioid consumption in the first postoperative day as the primary outcome. Effect size of 0.5 (medium effect size) was calculated using the difference between the mean opioid consumption in TAB group (140 mg) and that in ESPB group (124.6 mg) with an estimated standard deviation of 30 in both groups. This study will add a control group in which only intravenous analgesics will be used; hence the aforementioned effect size was used for sample size calculation using a one-way ANOVA test. Sample sizes of 18 patients in each group are needed to achieve 90% power (1-β) to detect differences among the means using an F test with a 0.05 significance level (α). The size of the variation in the means is represented by the effect size f = σm / σ, which is 0.5. A 20% drop out is expected so the drop-out inflated sample size will be 23 patients in each group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03940885
Study type Interventional
Source Mansoura University
Contact Mona A Hasheesh, MD
Phone 01223912912947
Email drmonahasheesh@hotmail.com
Status Recruiting
Phase N/A
Start date April 1, 2019
Completion date June 2021

See also
  Status Clinical Trial Phase
Completed NCT03143959 - Functional Improvement With Abdominoplasty N/A
Active, not recruiting NCT04207047 - Histologic Evaluation of Tissue Following Lutronic System Exposure N/A
Active, not recruiting NCT04712331 - Effect of Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty N/A
Completed NCT02949778 - Quadratus Lumborum Block for Abdominoplasty Phase 4
Active, not recruiting NCT01026662 - In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue Phase 2/Phase 3
Withdrawn NCT03770195 - Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Terminated NCT03429556 - Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty Phase 2
Terminated NCT02302222 - The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing N/A
Recruiting NCT05939518 - Fluid Therapy and Glycocalyx Shedding During Moderate Surgery N/A
Active, not recruiting NCT05490602 - Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes
Completed NCT01389635 - Abdominoplasty Under Epidural Anesthesia N/A
Recruiting NCT04670224 - Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery N/A
Recruiting NCT03190876 - Seroma Prevention After Body Contouring Procedures N/A
Recruiting NCT04787874 - Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures N/A
Completed NCT01604694 - Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty Phase 4
Withdrawn NCT02140385 - Role of Preservation of Scarpa's Fascia in Abdominoplasty N/A
Completed NCT04182880 - Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain Phase 2
Completed NCT03467724 - Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift N/A
Not yet recruiting NCT02930447 - Evaluation of the Benefit of the Use of Autologous Glue Prepared With RegenKit®-Surgery Device in Abdominoplasty N/A
Enrolling by invitation NCT06043557 - Patient Satisfaction and Reflection on Drain Placement N/A