Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial

Abstract

Background: Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal spaceoccupying 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 only maintained for a relatively short period of time. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet.Methods: The PRE-EASE trial 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-h 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…”

Pre-emptive coinfiltration of dexamethasone palmitate emulsion with ropivacaine for postoperative pain in patients undergoing major spine surgery: a study protocol for a prospective, randomised controlled, multicentre trial

“…The epidural space and intrathecal space will not be infiltrated. The volume of infiltrated solution per surgical level will be determined by the responsible neurosurgeon according to the thickness of the incision site, up to a maximum of 10 mL per surgical level will be injected 31. The total volume of infiltrated solution will be recorded by the researcher.…”

Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial

“…Other systemic analgesic drugs, for example, nonsteroidal anti-inflammatory drugs (NSAIDs), gabapentin, and ketamine, appear to be effective, but none are considered adequate to alleviate pain without risks for neurological recovery [ 6 ]. Furthermore, systemic administration is usually used after the occurrence of pain when the peripheral and central sensitizations have already developed, leading to less pronounced analgesic effects [ 7 ]. Hence, it is important to explore multimodal analgesia to provide better pain control and to minimize the reliance on systemic analgesics [ 8 ].…”