Evidence map›Paper›PMID 37225277›Full record

ArticleBMJ open2023

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.

Bin Yu, Baoguo Wang, Niti Shrestha, Fang Luo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05693467 (Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.3field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05693467 phase4completednot on this map

Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery

TypeinterventionalSponsorBeijing Tiantan HospitalRan2023 to 2023Enrolled124ConditionsPain, PostoperativeArmsDexamethasone palmitate emulsion(DXP) plus ropivacaine, Ropivacaine alone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Bin Yu *Department of Day Surgery, Beijing Tiantan Hospital, Beijing, China.
Baoguo Wang *Department of Anesthesiology, Capital Medical University Sanbo Brain Hospital, Haidian District, Beijing, China.
Niti ShresthaDepartment of Pain Management, Beijing Tiantan Hospital, Beijing, China.ORCID 0000-0001-7360-9747
Fang LuoDepartment of Pain Management, Beijing Tiantan Hospital, Beijing, China 13611326978@163.com.ORCID 0000-0002-3584-0355
Beijing Tian Tan Hospital · CNCapital Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: NCT05693467.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPostoperative PainDexamethasoneEmulsionsHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicRopivacaineDexamethasoneEmulsionsRopivacaineadult anaesthesiapain managementspine

Identifiers

PMID37225277
PMCPMC10231017
OpenAlexW4377982483

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.