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Record W3127291391 · doi:10.1186/s13063-021-05275-9

Continuous erector spinae plane block versus thoracic epidural analgesia in video-assisted thoracic surgery: a study protocol for a prospective randomized open label non-inferiority trial

2021· article· en· W3127291391 on OpenAlexaff
Renee van den Broek, J. S. H. A. Koopman, Jonne M C Postema, Niels Verberkmoes, Ki Jinn Chin, R. Arthur Bouwman, Barbara Versyck

Bibliographic record

VenueTrials · 2021
Typearticle
Languageen
FieldMedicine
TopicAnesthesia and Pain Management
Canadian institutionsToronto Western HospitalUniversity of Toronto
Fundersnot available
KeywordsMedicineAnesthesiaVideo-assisted thoracoscopic surgeryRandomized controlled trialLocal anestheticSurgeryCardiothoracic surgery

Abstract

fetched live from OpenAlex

BACKGROUND: Thoracic epidural analgesia is considered the gold standard for pain relief in video-assisted thoracoscopic surgery. This neuraxial technique blocks pain sensation by injecting a local anesthetic agent in the epidural space near the spinal cord to block spinal nerve roots. Recently, the erector spinae plane block has been introduced as a practical alternative to the thoracic epidural. This interfascial regional anesthesia technique interrupts pain sensation by injecting a local anesthetic agent in between the muscular layers of the thoracic wall. Several case series and three RCTs described it as an effective pain management technique in video-assisted thoracoscopic surgery (Scimia et al., Reg Anesth Pain Med 42:537, 2017; Adhikary et al., Indian J Anaesth 62:75-8, 2018; Kim, A randomized controlled trial comparing continuous erector spinae plane block with thoracic epidural analgesia for postoperative pain management in video-assisted thoracic surgery, n.d.; Yao et al., J Clin Anesth 63:109783, 2020; Ciftci et al., J Cardiothorac Vasc Anesth 34:444-9, 2020). The objective of this study is to test the hypothesis that a continuous erector spinae plane block incorporated into an opioid-based systemic multimodal analgesia regimen is non-inferior in terms of the quality of postoperative recovery compared to continuous thoracic epidural local anesthetic-opioid analgesia in patients undergoing elective unilateral video-assisted thoracoscopic surgery. METHODS: This is a prospective randomized open label non-inferiority trial. A total of 90 adult patients undergoing video-assisted thoracoscopic surgery will be randomized 1:1 to receive pain treatment with either (1) continuous erector spinae plane block plus intravenous patient-controlled analgesia with piritramide (study group) or (2) continuous thoracic epidural analgesia with a local anesthetic-opioid infusate (control group). All patients will receive additional systemic multimodal analgesia with paracetamol and non-steroidal anti-inflammatory drugs. The primary endpoint is the quality of recovery as measured by the Quality of Recovery-15 score. Secondary endpoints are postoperative pain as Numerical Rating Score scores, length of hospital stay, failure of analgesic technique, postoperative morphine-equivalent consumption, itching, nausea and vomiting, total operative time, complications related to surgery, perioperative hypotension, complications related to pain treatment, duration of bladder catheterization, and time of first assisted mobilization > 20 m and of mobilization to sitting in a chair. DISCUSSION: This randomized controlled trial aims to confirm whether continuous erector spinae plane block plus patient-controlled opioid analgesia can equal the analgesic effect of a thoracic epidural local anesthetic-opioid infusion in patients undergoing video-assisted thoracoscopic surgery. TRIAL REGISTRATION: Netherlands Trial Register NL6433 . Registered on 1 March 2018. This trial was prospectively registered.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.024
metaresearch head score (Gemma)0.012
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.041
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0240.012
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0050.001
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.226
GPT teacher head0.488
Teacher spread0.262 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designRandomized trial
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations11
Published2021
Admission routes1
Has abstractyes

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