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

Chunmei Zhao, Shaoheng Wang, Yuesong Pan, Nan Ji, Fang Luo, Chunmei Zhao, Shaoheng Wang, Yuesong Pan, Nan Ji, Fang Luo

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).

Keywords: craniotomy; dexamethasone; incision-site infiltration; postoperative pain; randomized controlled trial.

Conflict of interest statement

The authors declare that they have no conflicts of interest.

© 2021 Zhao et al.

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Perioperative heart rate (HR) and mean arterial pressure (MAP).
Figure 3
Figure 3
Kaplan-Meier estimation of the first analgesia demand press time among patients who were given dexamethasone as an adjuvant (dexamethasone group) or ropivacaine alone (control group) to pre-emptive incision-site infiltration.
Figure 4
Figure 4
Postoperative numeral rating scale (NRS) (A) and patient satisfaction scale (PSS) (B) scores.
Figure 5
Figure 5
Mean differences in primary outcome of the prespecified subgroups. The reduction in sufentanil consumption within the first 48 hours after craniotomy with pre-emptive incision-site infiltration with the ropivacaine plus dexamethasone group (dexamethasone group), when compared with the ropivacaine alone group (control group), was consistent across all prespecified subgroups. There were no significant interactions in any of the 7 predefined subgroups (P>0.10 for all comparisons). *Other locations included occipito-temporal, fronto-parietal, temporo-parietal, parieto-occipital.

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