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

NCT03940885 | Unknown DMC

• 1 other identifier: MD.19.03.155
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  cumulative consumption of rescue opioids during the first postoperative day

  For 24 hours after performing block

Secondary Outcomes (7)

• Duration of analgesia

  for 24 hours after performing block

• Postoperative visual analogue score

  for 24 hours after performing block

• Cortisol level

  For one hour after performing block

• Heart rate

  For 24 hours after surgery

• Mean arterial blood pressure

  For 24 hours after surgery

Study Arms (3)

Erector spinea plane block group

ACTIVE COMPARATOR

this group is planned for ultrasound-guided Transversus abdominis plane block

Procedure: Erector spinea plane block group

Transversus abdominis plane block

ACTIVE COMPARATOR

this group is planned for ultrasound-guided Transversus abdominis plane block

Procedure: Transversus abdominis plane block

Control group

PLACEBO COMPARATOR

standard general anesthesia

Procedure: Control group

Interventions

Erector spinea plane block group PROCEDURE

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

Erector spinea plane block group

Transversus abdominis plane block PROCEDURE

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

Transversus abdominis plane block

Control group PROCEDURE

this group will receive only standard general anesthesia

Control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologist grade I-II

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Hanaa M Elbendary

Al Mansurah, DK, 050, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 27141108 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hanaa M Elbendary, MD

  Anesthesia Department, Faculty of Medicine, Mansoura University

  STUDY CHAIR

Central Study Contacts

Mona A Hasheesh, MD

CONTACT

01223912912947; drmonahasheesh@hotmail.com

Hanaa M Elbendary, MD

CONTACT

00201005781768; hanaa_elbendary@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-blind study

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available following completing the study for life-long
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients

Locations

EG (1)