Dataset Information

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).

SUBMITTER: Zhao C

PROVIDER: S-EPMC8064677 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionPatients undergoing major spine surgery usually experience moderate-to-severe postoperative pain. It has been shown that dexamethasone as an adjunct to local anaesthesia (LA) infiltration presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis reported that the overall benefits of dexamethasone infiltration were marginal. Dexamethasone palmitate (DXP) emulsion is a targeted liposteroid. Compared with dexamethasone, DXP has a stronger anti-inflammatory effect, longer duration of action and fewer adverse effects. We hypothesised that the additive analgesic effects of DXP on local incisional infiltration in major spine surgery may have better postoperative analgesic effect, compared with local anaesthetic alone. However, no study has evaluated this so far. The purpose of this trial is to determine whether pre-emptive coinfiltration of DXP emulsion and ropivacaine at surgical site incision will further reduce postoperative opioid requirements and pain scores after spine surgery than that with ropivacaine alone.Methods and analysisThis is a prospective, randomised, open-label, blinded endpoint, multicentre study. 124 patients scheduled for elective laminoplasty or laminectomy with no more than three levels will be randomly allocated in a 1:1 ratio into two groups: the intervention group will receive local incision site infiltration with ropivacaine plus DXP; the control group will receive infiltration with ropivacaine alone. All participants will complete a 3 months follow-up. The primary outcome will be the cumulative sufentanil consumption within 24 hours after surgery. The secondary outcomes will include further analgesia outcome assessments, steroid-related side effects and other complications, within the 3 months follow-up period.Ethics and disseminationThis study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital (KY-2019-112-02-3). All participants will provide a written informed consent. The results will be submitted for publication in a peer-reviewed journals.Trial registration numberNCT05693467.

Project description:BackgroundPostoperative pain after laminoplasty and laminectomy occurs partially from local trauma of the paraspinal tissue. Finding a multimodal analgesic cocktail to enhance the duration and effect of local infiltration analgesia is crucial. Because of rapid onset and long duration of action of betamethasone, we hypothesized that, a preemptive multimodal infiltration regimen of betamethasone and ropivacaine reduces pain scores and opioid demand, and improves patient satisfaction following laminoplasty and laminectomy.Materials and methodsThis prospective, randomized, open-label, blinded endpoint study was conducted between September 1, 2021 and June 3, 2022, and included patients between the ages of 18 to 64 scheduled for elective laminoplasty or laminectomy under general anesthesia, with American Society of Anesthesiologists classification I/II. 116 patients were randomly assigned to either the BR (Betamethasone-Ropivacaine) group or the R (Ropivacaine) group in a 1:1 ratio. Each group received preemptive infiltration of a total of 10 ml study solution into each level. Every 30 ml of study solution composed of 0.5 ml of Betamethasone plus 14.5 ml of saline and 15 ml of 1% ropivacaine for the BR group, and 15 ml of 1% ropivacaine added to 15 ml of saline for the R group. Infiltration of epidural space and intrathecal space were avoided and spinous process, transverse process, facet joints and lamina were injected, along with paravertebral muscles and subcutaneous tissue. Cumulative 48 hours postoperative butorphanol consumption via PCA (Patient-controlled analgesia) was the primary outcome. Intention-to-treat (ITT) principle was used for primary analysis.ResultsBaseline characteristics were identical in both groups (P>0.05). The cumulative 48 hours postoperative butorphanol consumption via PCA was 3.01.4 mg in the BR group (n=58), and 7.11.2 mg in the R group (n=58) (P<0.001). Overall cumulative opioid demand was lower at different time intervals in the BR group (P<0.001), along with the estimated median time of first analgesia demand via PCA (3.3 hours in the BR group and 1.6 hours in the R group). Visual Analogue Scale (VAS) score at movement and rest were also significantly lower until 3 months and 6 weeks, respectively. No side effects or adverse events associated with the intervention were observed in this study.ConclusionsPreemptive analgesia with betamethasone and ropivacaine provides better postoperative pain management following laminoplasty and laminectomy, compared to ropivacaine alone. This is an effective technique worthy of further evaluation.