Evidence map›Paper›PMID 28562541›Full record

Trial reportMedicine2017

Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).

Joon-Hyop Lee, Yong Joon Suh, Ra-Yeong Song, Jin Wook Yi, Hyeong Won Yu, Hyungju Kwon, June Young Choi, Kyu Eun Lee

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

Trial report in Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02112370 (Phase 3 Study of Ropivacaine), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT02112370 phase3completednot on this map

Phase 3 Study of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy

TypeinterventionalSponsorSeoul National University HospitalRan2014 to 2016Enrolled148ConditionsThyroid Neoplasm, GoiterArmsRopivacaine with epinephrine injection, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Safety of pre-incisional low-dose ropivacaine infiltration in bilateral axillo-breast approach thyroidectomy: a retrospective study.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2022
    Article
  5. Review
  6. Review
  7. 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

8 authors at 4 institutions in 3 countries.

Joon-Hyop LeeDepartment of Surgery, Seoul National University Bundang Hospital, Gyeonggi-do Department of Surgery, Seoul National University Hospital and College of Medicine Cancer Research Institute, Seoul National University College of Medicine, Seoul Thyroid and Endocrine Surgery Section, Department of Surgery, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Yong Joon Suh
Ra-Yeong Song
Jin Wook Yi
Hyeong Won Yu
Hyungju Kwon
June Young Choi
Kyu Eun Lee
Seoul National University Hospital · KRSeoul National University Bundang Hospital · KRGachon University Gil Medical Center · KRNew Generation University College · ET

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials on bilateral axillo-breast approach (BABA) thyroidectomy show that levobupivacaine and ropivacaine significantly reduce postoperative pain, but they focused on BABA robotic thyroidectomy only and did not identify specific sites of significant pain relief. Our objective was to assess the pain reduction at various sites and safety of ropivacaine-epinephrine flap injection in BABA thyroidectomy.

methodsThis prospective double-blinded randomized controlled trial was conducted in compliance with the revised CONSORT statement (ClinicalTrials.gov registration no. NCT02112370). Patients were randomized into the ropivacaine-epinephrine arm or control (normal saline) arm.

resultsFrom January 2014 to May 2016, 148 patients participated. The primary endpoint was site-specific pain, as measured by numeric rating scale 12 hours after surgery. The ropivacaine-epinephrine group exhibited significantly less swallowing difficulty (P = .008), anterior neck pain (P = .016), and right (P = .019) and left (P = .035) chest pain. Secondary endpoints were systolic (P = .402), diastolic (P = .827) blood pressure, and pulse rate (P = .397) after injection before incision and during surgery. The vital signs of the groups just after injection did not differ. During surgery, the ropivacaine-epinephrine patients had higher pulse rates (99 ± 13.3 vs 88 ± 16.1, P < .001) but within normal range. There were no adverse events such as postoperative nausea and vomiting. There was no significant difference in pain scores in either patient group between patients who underwent robotic or endoscopic interventions.

conclusionBABA flap-site injection with ropivacaine and epinephrine mix before incision effectively and safely reduced postoperative pain. Future studies should focus on tailoring ropivacaine and epinephrine dosage for individuals.

Indexed as

Surgical FlapsThyroidectomyAdultAmidesAnesthetics, LocalDouble-Blind MethodDrug Therapy, CombinationEndoscopyEpinephrineFemaleHumansMaleMonitoring, IntraoperativeOperative TimePain MeasurementPostoperative PainAmidesAnesthetics, LocalEpinephrineRopivacaine

Identifiers

PMID28562541
PMCPMC5459706
OpenAlexW2616945958

What OpenQuestion holds

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LicenceCC BY-ND
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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.