Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit.
The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids.
Inadequate post-operative pain control can lead to adverse consequences for patients, such as the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as well as adrenergic activation and its consequences in the form of coronary incidents or gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of mobility can result in thrombosis and embolism. These complications affect hospital functioning, which leads to decreased patient satisfaction, a worse reputation for the hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of re-surgeries and re-admissions, and higher costs for care and treatment.
Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4 cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a study of 3 cases. When performed at the level of the T7 transverse process, studies show the potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are mostly case studies done in this field of study, and internationally there is a call for research into the effect of this technique and randomized controlled trials.
The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing ventral hernia repair.
Hypothesis, aims and objectives
The postulated nullhypothesis and alternativ hypothesis is:
H0= there is no difference in opioid consumption postoperatively between multimodal analgesia and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard multimodal analgesia and ESPB.
Sample size calculation
Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and in order to show a 50% reduction in rescue opioid consumption after a successful block with 80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied, total of 52 patients. In order to adjust for missing data and protocol violations we decided to include 2 x 30 patients in our study.
This is a study where all parties are blinded for the allocation. A study nurse draws up the allocated study medication in an unmarked syringe so that the anesthesiologist is blinded. The study nurse responsible for the medication is not the same nurse that does the postoperative scoring. The study nurse responsible for the medication puts masked containers of the allocated medication into opaque envelopes and delivers the envelope to the ward. The ward personnel will then be masked for the allocation. The study nurse responsible for the follow up calls are not the same study nurse responsible for the medications and as such is also blinded for the allocation.
The primary outcome measure is the opiate consumption measured in oral morphine equivalents after 1 hour.
Secondary outcome measures are;
After the operation the patients will be asked to answer the QoR-15, which consist of 15 questions distributed on two dimensions: "physical" and "mental" well-being, where the patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire. The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L is comprised of two different measures; the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.
The objective is to gain knowledge to support anesthesiologists when deciding analgesic approach, as well as in shared decision-making with patients (including the patient perspective). All results are expected to be presented during the project period.
The inclusion criteria:
The exclusion criteria;