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

NCT ID: NCT03940885

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-30

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.

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.

Conditions

Abdominoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Erector spinea plane block group

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

Group Type: ACTIVE_COMPARATOR

Erector spinea plane block group

Intervention Type: 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

Transversus abdominis plane block

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

Group Type: ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type: 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

Control group

standard general anesthesia

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: PROCEDURE

this group will receive only standard general anesthesia

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Control group

this group will receive only standard general anesthesia

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanaa M Elbendary, MD

Role: STUDY_CHAIR

Anesthesia Department, Faculty of Medicine, Mansoura University

Locations

Hanaa M Elbendary

Al Mansurah, DK, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mona A Hasheesh, MD

Role: CONTACT

drmonahasheesh@hotmail.com

01223912912947

Hanaa M Elbendary, MD

Role: CONTACT

hanaa_elbendary@yahoo.com

00201005781768

Facility Contacts

Hanaa M Elbendary, MD

Role: primary

hanaa_elbendary@yahoo.com

00201005781768 ext. 00201005781768

Mona A Hasheesh, MD

Role: backup

drmonahasheesh@hotmail.com

References

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.

Reference Type: RESULT

PMID: 27141108 (View on PubMed)

Other Identifiers

MD.19.03.155

Identifier Type: -

Identifier Source: org_study_id