Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): A Study Protocol for a Randomized Controlled Trial

Abstract

Background: Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. Intense immediate postoperative pain after many spinal procedures makes its control of utmost importance.Preemptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomyhas better short-term and long-term effects than the local anesthetic alone has not been reported yet. Method: The PRE-EASEtrial is a prospective, randomized, open-label, blinded endpoint, single-center clinical study including 116 participants scheduled for elective laminoplasty or laminectomy, with a 6 months’ follow-up process. Preemptive local infiltration with betamethasone and ropivacaine (treatment group) or ropivacaine alone (control group) throughout the entire thickness of the planned incision site will be performed by the surgeon, prior to making the incision. The primary outcome will be the cumulative butorphanol consumption within the first 48 hours’ postoperative period. Discussion: This study will add significant new knowledge to the effect and feasibility of preemptive local infiltration of betamethasone for postoperative pain management in laminoplasty and laminectomy.

Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial

“…No patient in this study experienced hypotensive emergency and respiratory depression within 48 hours after postoperatively. The LOS was not significantly different between the 2 groups (13 [11][12][13][14] days in the Diprospan group and 14 [12][13][14][15][16] days in the control group; P = .24; Table 3).…”

“…10 Therefore, it is necessary to explore other compatible drugs with longer duration of action and stronger analgesic effects. 11 Incisional pain leads to the release of inflammatory mediators after tissue damage 12 ; therefore, reducing incisional inflammation could become an effective strategy to control incisional pain. Our research group has previously established that preoperative incisionsite infiltration with dexamethasone, which possesses an anti-inflammatory effect, along with ropivacaine, a local anesthetic, has a better postoperative analgesic effect than ropivacaine alone in craniotomy patients; however, the effect was limited.…”

“…10 Therefore, it is necessary to explore other compatible drugs with longer duration of action and stronger analgesic effects. 11…”

New peripheral nerve blocks and local anesthetics

“…Diprospan, a corticosteroid containing both rapid and long-acting betamethasone, is being studied as an adjunct to Ropivacaine for local infiltration in two recent phase IV trials in patients undergoing craniotomies and laminectomies respectively [62,63].…”