Evidence map›Paper›PMID 25270861›Full record

Trial reportBMJ open2014

Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

R Langford, I Brown, J Vickery, K Mitchell, C Pritchard, S Creanor

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04309929 (Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 28% 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.

NCT04309929 completednot on this mapstarted 2016, after this paper: background citation

Description of the Analgesia Obtained With the Anesthesiological Protocols Currently Used in Breast Surgery

TypeobservationalSponsorCareggi HospitalRan2016 to 2018Enrolled200ConditionsBreast CancerArmsAnalgesics
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
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

6 authors at 4 institutions in 1 country.

R LangfordDepartment of Anaesthesia, Royal Cornwall Hospital, Truro, UK.
I BrownDepartment of Surgery, Royal Cornwall Hospital, Truro, UK.
J VickeryPeninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
K MitchellDepartment of Anaesthesia, Royal Cornwall Hospital, Truro, UK.
C PritchardNIHR Research Design Service (South West), Truro, UK.
S CreanorCentre for Biostatistics, Bioinformatics & Biomarkers, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
Royal Cornwall Hospital · GBNIHR Clinical Research Network · GBPeninsula College of Medicine and Dentistry · GBUniversity of Plymouth · GB

Funding

Department of Health PB-PG-0610-22342
6 · The paper itself

Abstract

introductionOver 16 000 mastectomies are performed in England and Wales annually. Acute postoperative pain and nausea are common. The most frequently occurring long-term complications are chronic pain (up to 50%) and reduced shoulder function (reported at 35%). Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications. This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy. METHODS AND ANALYSIS: This is a randomised, double blind, placebo-controlled, two-centre, parallel group trial in women undergoing mastectomy with or without axillary involvement. One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25% levobupivacaine or 0.9% saline by subpectoral infusion postoperatively for 24 h. All participants will be provided with an intravenous morphine patient-controlled analgesia (PCA) system. Participants will be followed-up for 24 h in hospital and at approximately 14 days and 6 months postoperatively. Joint primary outcome measures are total morphine consumption and total pain score (captured via patient-recorded visual analogue scale (VAS) 4 hourly) during the first 24 h postoperatively. Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph. Secondary outcomes include PCA attempts in first 24 h; VAS pain scores and shoulder function by goniometry at 24 h, 14 days (approximately) and 6 months; Verbal Rating Scale pain scores in first 24 h; Brief Pain Inventory and Oxford Shoulder Score at 6 months; duration of hospital stay; incidence of postoperative nausea and vomiting; cost-effectiveness. ETHICS AND DISSEMINATION: The study is approved by the South West England Research Ethics Committee (12/SW/0149).

resultswill be published in a peer-reviewed journal and presented at local, national and international scientific meetings.

trial registrationISRCTN46621916. EudraCT 2011-005775-16.

Indexed as

Analgesia, Patient-ControlledAnesthetics, LocalBupivacaineClinical ProtocolsDouble-Blind MethodFemaleHumansInfusions, IntravenousLevobupivacaineMastectomyPain MeasurementPostoperative PainQuality of LifeShoulderAnesthetics, LocalBupivacaineLevobupivacaineAnaesthetic infusionLocal AnaestheticMastectomyPainShoulder function

Identifiers

PMID25270861
PMCPMC4179566
OpenAlexW2169985979

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.