Dataset Information

Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial.

ABSTRACT:

Introduction

Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrease opioid consumption and improve analgesia in urological surgery. Therefore, we aimed to explore whether ESPB would have similar analgesia compared with thoracic paravertebral block (TPVB) in laparoscopic nephroureterectomy.

Methods and analysis

This prospective, randomized, double-blinded, non-inferiority trial will enroll 166 patients undergoing laparoscopic nephroureterectomy. Participants will be randomly assigned 1:1 into receiving ESPB or TPVB before surgery. Both ultrasound-guided ESPB and TPVB will be performed with an injection of 0.375% ropivacaine 0.4 ml/kg before anesthesia induction. Standardized patients controlled intravenous analgesia (PCIA) will be applied for each patient. The primary endpoint is the joint of cumulative 24 h opioid (sufentanil) consumption and average pain score via numeric rating scale (NRS) at 24 h after surgery. Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery. Other predefined outcomes include clinical features of blockage, quality of recovery, subjective sleep quality, time to ambulation and diet, and adverse events, as well as length of stay in hospital and anesthesia cost.

Discussion

Previous studies investigating the analgesic efficacy of ESPB only concentrated on a single endpoint for postoperative pain evaluation, while studies focusing on the direct comparison between ESPB and TPVB in urological surgery are still lacking. Our study is the first trial in non-inferiority design of comparing ESPB and TPVB in patient undergoing laparoscopic nephroureterectomy, and the primary outcome is the joint endpoint of opioid consumption and pain NRS score.

Trial registration

Chinese Clinical Trial Registry ChiCTR 2000031916 . Registered on 14 April 2020.

SUBMITTER: Xu ZZ

PROVIDER: S-EPMC8022408 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundParavertebral block (PVB) is the most recognized regional anesthesia technique after thoracic epidural anesthesia for postoperative analgesia in thoracic and breast surgery. Erector spinae plane block (ESPB) is a recently discovered blocking technique, and it has evidenced excellent postoperative analgesia for breast and thoracic surgery with fewer adverse reactions. However, there are controversies about the postoperative analgesic effects of the two analgesic techniques.ObjectiveTo assess the analgesic effects of PVB versus ESPB in postoperative thoracic and breast surgery.MethodsWe systematically searched PubMed, Cochrane Library, EMBASE, Web of Science, and ScienceDirect databases up to April 5, 2021. The primary outcome was postoperative pain scores. Secondary outcomes included: opioid consumption, additional analgesia, postoperative nausea and vomiting (PONV) 24 hours post-operation, and the time required for completing block procedure. This study was registered in PROSPERO, number CRD42021246160.ResultsAfter screening relevant, full-text articles, ten randomized controlled trials (RCTs) that met the inclusion criteria were retrieved for this meta-analysis. Six studies involved thoracic surgery patients, and four included breast surgery patients. Thoracic surgery studies included all of the outcomes involved in this meta-analysis while breast surgery did not report pain scores at movement and additional analgesia in 24 hours post-operation. For thoracic surgery, PVB resulted in significant reduction in the following pain scores: 0-1 hours (MD = -0.79, 95% CI: -1.54 to -0.03, P = 0.04), 4-6 hours (MD = -0.31, 95% CI: -0.57 to -0.05, P = 0.02), and 24 hours (MD = -0.42, 95% CI: -0.81 to -0.02, P = 0.04) at rest; significant reduction in pain scores at 4-6 hours (MD = -0.47, 95% CI: -0.93 to -0.01, P = 0.04), 8-12 hours (MD = -1.09, 95% CI: -2.13 to -0.04, P = 0.04), and 24 hours (MD = -0.31, 95% CI: -0.57 to -0.06, P = 0.01) at movement. Moreover, the opioid consumption at 24 hours post-operation (MD = -2.74, 95% CI: -5.41 to -0.07, P = 0.04) and the incidence of additional analgesia in 24 hours of the postoperative course (RR: 0.53, 95% CI: 0.29 to 0.97, P = 0.04) were significantly lower in the PVB group than in the ESPB group for thoracic surgery. However, no significant differences were found in pain scores at rest at various time points postoperatively, and opioid consumption at 24 hours post-operation for breast surgery. The time required for completing block procedure was longer in the PVB group than in the ESPB group for thoracic and breast surgery, and the incidence of PONV between the two groups showed no significant difference.ConclusionThe postoperative analgesic effects of PVB versus ESPB are distinguished by the surgical site. For thoracic surgery, the postoperative analgesic effect of PVB is better than that of ESPB. For breast surgery, the postoperative analgesic effects of PVB and ESPB are similar.

Project description:BackgroundPostoperative analgesia in breast surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast; general anesthesia can be associated with regional anesthesia techniques to control intra- and post-postoperative pain. This randomized comparative study aimed to compare the efficacy of the erector spinae plane block and the thoracic paravertebral block in radical mastectomy procedures with or without axillary emptying.MethodsThis prospective randomized comparative study included 82 adult females who were randomly divided into two groups using a computer-generated random number. Both groups, Thoracic Paraverterbal block group and Erector Spinae Plane Block group (41 patients each), received general anesthesia associated with a multilevel single-shot thoracic paravertebral block and a multilevel single-shot erector spinae plane block, respectively. Postoperative pain intensity (expressed as Numeric Rating Scale), patients who needed rescue analgesic, intra- and post-operative opioid consumption, post-operative nausea and vomiting, length of stay, adverse events, chronic pain at 6 months, and the patient's satisfaction were recorded.ResultsAt 2 h (p < 0.001) and 6 h (p = 0.012) the Numeric Rating Scale was significantly lower in Thoracic Paraverterbal block group. The Numeric Rating Scale at 12, 24, and 36 postoperative hours did not show significant differences. There were no significant differences also in the number of patients requiring rescue doses of NSAIDs, in intra- and post-operative opioid consumption, in post-operative nausea and vomiting episodes and in the length of stay. No failures or complications occurred in the execution of techniques and none of the patients reported any chronic pain at six months from the surgery.ConclusionsBoth thoracic paravertebral block and erector spinae plane block can be effectively used in controlling post-mastectomy pain with no significant differences between the two blocks.Trial registrationThe study was prospectively registered on Clinicaltrials.gov (trial identifier NCT04457115) (first registration 27/04/2020).