Evidence map›Paper›PMID 33856424›Full record

Trial reportAnesthesiology2021

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study.

Brian M Ilfeld, Anthony Plunkett, Alice M Vijjeswarapu, Robert Hackworth, Sandeep Dhanjal, Alparslan Turan, Steven P Cohen, James C Eisenach, Scott Griffith, Steven Hanling and 7 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Anesthesiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05971095 (Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty.), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
14.6field-weighted citation impact, top 1% 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.

NCT05971095 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty.

TypeinterventionalSponsorHospital General Universitario de ValenciaRan2023 to 2024Enrolled64ConditionsAcute PainArmsPercutaneous neuromodulation using the EPTE® Bipolar System device
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. 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

17 authors at 1 institution in 4 countries.

Brian M Ilfeld
Anthony Plunkett
Alice M Vijjeswarapu
Robert Hackworth
Sandeep Dhanjal
Alparslan Turan
Steven P Cohen
James C Eisenach
Scott Griffith
Steven Hanling
Daniel I Sessler
Edward J Mascha
Dongsheng Yang
Joseph W Boggs
Amorn Wongsarnpigoon
Harold Gelfand
PAINfRE Investigators
Cedars-Sinai Medical Center · US

Funding

Pain Management Collaboratory Coordinating Center (PMC3)U24AT009769 · NCCIH · YALE UNIVERSITY · PI WILLIAM C BECKER, Alicia Heapy · 2017 to 2026
$16.4M
NCCIH NIH HHS U24 AT009769
6 · The paper itself

Abstract

backgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.

methodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.

resultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).

conclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery. EDITOR’S PERSPECTIVE:

Indexed as

Implantable NeurostimulatorsFeasibility StudiesFemaleHumansMaleMiddle AgedPeripheral NervesPilot ProjectsPostoperative PainTranscutaneous Electric Nerve StimulationTreatment Outcome

Identifiers

PMID33856424
PMCPMC8249357
OpenAlexW3156414889

What OpenQuestion holds

Textmetadata
LicenceTDM
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.