Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial

Abstract

Background: Incision-site infiltration with local anesthetics prevents pain on incision site, but pain relief is limited to the first few postoperative hours. Dexamethasone as an adjuvant to local infiltration successfully achieves better postoperative pain relief; however, this has not been studied in craniotomy patients yet. Study Design and Methods: This is a prospective, single-center, blinded, randomized, controlled trial included patients aged between 18 and 64 years, ASA physical status of I-II, scheduled for elective supratentorial tumor craniotomy under general anesthesia. We screened patients for enrollment from April 4, 2019 through August 15, 2019. The final study visit of the last patient was conducted on February 13, 2020. We randomly assigned eligible participants (1:1) to either the dexamethasone group who received incision-site infiltration of 0.5% ropivacaine plus 0.033% dexamethasone (N=70) or the control group who received 0.5% ropivacaine alone (N=70). Primary outcome was the cumulative sufentanil consumption (μg) within 48 hours postoperatively. Primary analysis was performed based on the modified intention-to-treat (MITT) principle. Results: Baseline characteristics were similar between the groups (p>0.05). Sufentanil consumption during the first 48 hours postoperatively was 29.0 (10.7) μg in the dexamethasone group and 38.3 (13.7) μg in the control group (mean difference −9.3, 95% CI −13.4 to −5.1; p<0.001). There was no serious adverse effect directly associated with incision-site infiltration or local dexamethasone use. Conclusion:The addition of dexamethasone to pre-emptive incision-site infiltration with the local anesthetic can reduce about 27% of opioids consumption and the postoperative pain scores within 72 hours after craniotomy. Trial Registration: ClinicalTrials.Gov (NCT03618264).

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

“…Therefore, dexamethasone is preferred for injection in consideration of effectiveness and safety. Pre-emptive scalp infiltration with the addition of dexamethasone sodium phosphate to 0.5% ropivacaine has ensured a significant decrease in opioids consumption and pain scores within postoperative 72 h, which is consistent with physiological effects of dexamethasone with a longer half-life of 36-72 h [ 6 , 21 ]. However, the positive results might have limited clinical significance concerning the absolute differences compared to the control group, which have also been observed in pediatric patients [ 6 , 22 ].…”

“…Earlier studies have reported that incision-site infiltration with ropivacaine plus dexamethasone could reduce about 30-50% of postoperative pain severity compared with ropivacaine alone [ 6 , 19 , 22 ]. Based on these literatures and our clinical experience, we hypothesize that the pain NRS scores was approximately 2.0 ± 1.5 (mean ± standard deviation) scores in the ropivacaine alone group and attempt to detect a difference of 40% in pain NRS scores between groups at 24 h after craniotomy.…”

“…So opioids are often used sparingly for fear of adverse effects. 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 ].…”

Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial

“…Induction of anaesthesia was done using midazolam 0.03 mg/kg, sufentanil 0.3 to 0.4 μ g/kg, propofol 1.5 to 2 mg/kg, and cisatracurium 0.2 mg/kg or 0.6 mg/kg rocuronium [ 13 ]. Mechanical ventilation was provided via endotracheal tube intubation with intravenous propofol 4 to 8 mg/kg/hr and remifentanil 0.1 to 0.3 μ g/kg/min [ 14 ]. To maintain mean arterial pressure and heart rate fluctuations within a 20% range of baseline, additional doses of vasoactive drugs were administered [ 2 ].…”

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

“…Our research group has previously established that preoperative incision-site 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. 13,14 Yavari et al 15 report that, during 24 to 72 hours after endodontic treatment of vital teeth, the analgesic effect of infiltration of dexamethasone and long-acting (LA) betamethasone was the same, but dexamethasone had a better effect in the first 24 hours, and the analgesic effect of LA betamethasone can last up to 7 days. Diprospan is a combination of quick-acting betamethasone sodium phosphate and LA betamethasone dipropionate.…”