Abdominoplasty
Conditions
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.
Interventions
PROCEDUREErector 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
PROCEDURETransversus 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
PROCEDUREControl group
this group will receive only standard general anesthesia
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
single-blind study
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | For 24 hours after performing block | cumulative consumption of rescue opioids during the first postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative visual analogue score | 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 |
| Cortisol level | For one hour after performing block | Cortisol level will be assayed in the serum |
| Heart rate | For 24 hours after surgery | Changes in heart rate |
| Duration of analgesia | for 24 hours after performing block | the first time patient requests analgesia postoperatively |
| Peripheral oxygen saturation | For 24 hours after surgery | Changes in peripheral oxygen saturation as measured with pulse oximetry |
| Nausea and vomiting | For 24 hour after surgery | 0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting |
| Mean arterial blood pressure | For 24 hours after surgery | Changes in mean arterial blood pressure |
Countries
Egypt
Contacts
Primary ContactMona A Hasheesh, MD
Backup ContactHanaa M Elbendary, MD
Outcome results
None listed