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NCT01983020 · ClinicalTrials.gov registry record · Phase 3

Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

A Phase 3 study, sponsored by Beth Israel Medical Center.

Completed
Registry status
Phase 3
Development phase
46
Enrollment target

NCT01983020: Completed Phase 3 study, sponsored by Beth Israel Medical Center.

NCT01983020 is a Phase 3 study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 46 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01983020, a Phase 3 study, has completed, sponsored by Beth Israel Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
46 participants
Enrollment target

Study Summary

This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

Primary Outcome

The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).

Interventions

  • DRUG Ketamine
  • OTHER Saline
  • DRUG Lidocaine

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2011-04
Est. Completion 2013-01
Phase Phase 3
Beth Israel Medical Center

44 total trials

What the finished NCT01983020 record still lists

NCT01983020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which Ketamine is the first listed.

NCT01983020 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01983020 about?

NCT01983020 is a clinical study titled "Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery". This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lido...

What is the current status of trial NCT01983020?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2011-04. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01983020?

The interventions under investigation include: Ketamine (DRUG), Saline (OTHER), Lidocaine (DRUG).

Who is sponsoring clinical trial NCT01983020?

This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01983020's enrollment target sits among peer trials

46 1868th of 2000 higher than 131 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01983020, the US trial registry maintained by the National Library of Medicine. NCT01983020 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.