Dataset Information

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

ABSTRACT:

Background

Post-craniotomy pain is a common occurrence which is associated with poor outcomes. Pre-emptive scalp infiltration with dexamethasone and ropivacaine has been proven effective in previous studies but with limited clinical significance. Dexamethasone palmitate emulsion (D-PAL) is a pro-drug incorporating dexamethasone into lipid microspheres with greater anti-inflammatory activity and fewer side effects than free dexamethasone. However, its effects in post-craniotomy pain management remain unknown. This study hypothesizes that pre-emptive scalp infiltration with ropivacaine plus D-PAL emulsion can achieve superior analgesic effects to ropivacaine alone in adult patients undergoing craniotomy.

Methods/design

This is a single center, randomized controlled trial enrolling 130 patients scheduled for supratentorial craniotomy, which is expected to last longer than 4 h. We compare the efficacy and safety for postoperative pain relief of ropivacaine plus D-PAL group and ropivacaine alone group following pre-emptive scalp infiltration. Primary outcome will be pain Numerical Rating Scale at 24 h postoperatively. Secondary outcomes will include further analgesia evaluations and drug-related complications within a follow-up period of 3 months.

Discussion

This is the first randomized controlled trial aiming to assess the possible benefits or disadvantages of D-PAL emulsion for incisional pain in craniotomy. It may provide an alternative to optimize pain outcome for neurosurgical patients.

Trial registration

ClinicalTrials.gov (NCT04488315). Registered on 19 July 2020.

SUBMITTER: Zhang W

PROVIDER: S-EPMC9743637 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

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

Zhang Wei W Li Chunzhao C Zhao Chunmei C Ji Nan N Luo Fang F

Trials 20221212 1

<h4>Background</h4>Post-craniotomy pain is a common occurrence which is associated with poor outcomes. Pre-emptive scalp infiltration with dexamethasone and ropivacaine has been proven effective in previous studies but with limited clinical significance. Dexamethasone palmitate emulsion (D-PAL) is a pro-drug incorporating dexamethasone into lipid microspheres with greater anti-inflammatory activity and fewer side effects than free dexamethasone. However, its effects in post-craniotomy pain manag ...[more]

PMID: 36510271

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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.

Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

Similar Datasets

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