Clinical trial NCT03940885: Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery
Official title: Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominoplasty
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Total opioid consumption
timeFrame: For 24 hours after performing block
Secondary outcomes:
measure: Duration of analgesia
timeFrame: for 24 hours after performing block
measure: Postoperative visual analogue score
timeFrame: for 24 hours after performing block
measure: Cortisol level
timeFrame: For one hour after performing block
measure: Heart rate
timeFrame: For 24 hours after surgery
measure: Mean arterial blood pressure
timeFrame: For 24 hours after surgery
measure: Peripheral oxygen saturation
timeFrame: For 24 hours after surgery
measure: Nausea and vomiting
timeFrame: For 24 hour after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Hanaa M Elbendary
state: DK
Study officials:
affiliation: Anesthesia Department, Faculty of Medicine, Mansoura University
name: Hanaa M Elbendary, MD
role: STUDY_CHAIR
References:
citation: 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.