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

Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Abdominoplasty
• Intervention / Treatment: Procedure: Erector spinea plane block group; Procedure: Transversus abdominis plane block; Procedure: Control group

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 Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Recruiting
      • Hanaa M Elbendary
      • Contact: Hanaa M Elbendary, MD; Phone Number: 00201005781768 00201005781768; Email: hanaa_elbendary@yahoo.com
      • Contact: Mona A Hasheesh, MD; Email: drmonahasheesh@hotmail.com
      • Sub-Investigator: Tamer E Farahat, MD
      • Sub-Investigator: Ayat E Eid, MD

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	cumulative consumption of rescue opioids during the first postoperative day	For 24 hours after performing block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	the first time patient requests analgesia postoperatively	for 24 hours after performing block
Postoperative visual analogue score	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	for 24 hours after performing block
Cortisol level	Cortisol level will be assayed in the serum	For one hour after performing block
Heart rate	Changes in heart rate	For 24 hours after surgery
Mean arterial blood pressure	Changes in mean arterial blood pressure	For 24 hours after surgery
Peripheral oxygen saturation	Changes in peripheral oxygen saturation as measured with pulse oximetry	For 24 hours after surgery
Nausea and vomiting	0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting	For 24 hour after surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Mankikar MG, Sardesai SP, Ghodki PS. Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. Indian J Anaesth. 2016 Apr;60(4):253-7. doi: 10.4103/0019-5049.179451.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MD.19.03.155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Following completing recruiting and opening the dataset, the investigators would upload the raw data and results to the registry
• IPD Sharing Time Frame: The data will become available following completing the study for life-long
• IPD Sharing Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No