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Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery

  • Clinicaltrials.gov identifier

    NCT03940885

  • Recruitment Status

    Recruiting

  • First Posted

    May 7, 2019

  • Last update posted

    September 25, 2020

Study Description

Brief 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.

  • Condition or Disease:Abdominoplasty
  • Intervention/Treatment: Procedure: Erector spinea plane block group
    Procedure: Transversus abdominis plane block
    Procedure: Control group
  • Phase: N/A

Detailed 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

  • Study Type: Interventional
  • Estimated Enrollment: 69 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: single-blind study
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Supportive Care
  • Official Title: Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: June 2021

Arms and interventions

Arm Intervention/treatment
Active Comparator: Erector spinea plane block group
this group is planned for ultrasound-guided Transversus abdominis plane block
Procedure: Erector spinea plane block group
Which will receive ultrasound-guided erector spinea plane block bilaterally and the local anesthetic injected will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
Active Comparator: Transversus abdominis plane block
this group is planned for ultrasound-guided Transversus abdominis plane block
Procedure: Transversus abdominis plane block
Which will receive ultrasound-guided Transversus Abdominis plane block bilaterally and the local anesthetic used will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
Placebo Comparator: Control group
standard general anesthesia
Procedure: Control group
this group will receive only standard general anesthesia

Outcome Measures

  • Primary Outcome Measures: 1. Total opioid consumption [ Time Frame: For 24 hours after performing block ]
    cumulative consumption of rescue opioids during the first postoperative day
  • Secondary Outcome Measures: 1. Duration of analgesia [ Time Frame: for 24 hours after performing block ]
    the first time patient requests analgesia postoperatively
  • 2. Postoperative visual analogue score [ Time Frame: for 24 hours after performing block ]
    postoperative visual analogue score (VAS)which will be used to determine the postoperative pain levels in patients. ( 0 representing no pain and 10 is the worst imaginable pain) will be assessed at 2h, 4h,6h,12h,18h and 24h postoperative. Diclofenac75 mg IV and paracetamol 500 mg will be given to all patients in the three groups every 12 hours. If VAS is > 4 patient will receive pethidine 25 mg IV
  • 3. Cortisol level [ Time Frame: For one hour after performing block ]
    Cortisol level will be assayed in the serum
  • 4. Heart rate [ Time Frame: For 24 hours after surgery ]
    Changes in heart rate
  • 5. Mean arterial blood pressure [ Time Frame: For 24 hours after surgery ]
    Changes in mean arterial blood pressure
  • 6. Peripheral oxygen saturation [ Time Frame: For 24 hours after surgery ]
    Changes in peripheral oxygen saturation as measured with pulse oximetry
  • 7. Nausea and vomiting [ Time Frame: For 24 hour after surgery ]
    0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting

Eligibility Criteria

  • Ages Eligible for Study: 25 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- American society of anesthesiologist grade I-II

Exclusion Criteria:

- Patient refusal.

- Local skin infection and sepsis at the site of the block.

- Allergy to local anesthetic used.

- Hematological diseases

- Bleeding disease.

- Coagulation abnormality.

- Psychiatric disorders.

Contacts and Locations

Contacts

Contact: Mona A Hasheesh, MD 01223912912947 drmonahasheesh@hotmail.com

Contact: Hanaa M Elbendary, MD 00201005781768 hanaa_elbendary@yahoo.com

Locations

Egypt, DK
Hanaa M Elbendary
Mansourah

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Hanaa M Elbendary, MD Anesthesia Department, Faculty of Medicine, Mansoura University

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