NCT03817034

Brief Summary

The investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

November 23, 2018

Last Update Submit

March 28, 2021

Conditions

Pain

Keywords

multimodaldexmedetomidineropivacaineketorolacpain managementopioid sparinganalgesia

Outcome Measures

Primary Outcomes (2)

  • Change in post-operative opioid consumption

    Decreased post-operative opioid consumption associated with use of multimodal analgesia

    48 hours

  • Change in post-operative pain scores

    Decreased post-operative pain scores associated with use of multimodal analgesia

    48 hours

Study Arms (1)

Multimodal Analgesia

EXPERIMENTAL
Drug: Multimodal analgesia

Interventions

Multimodal analgesiaDRUG

Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac

Multimodal Analgesia

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • American Society of Anesthesiologist Physical Status Classification 1-3
  • Undergoing surgery requiring a rectus sheath block

You may not qualify if:

  • American Society of Anesthesiologist Physical Status Classification of 4 or beyond
  • history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Emery N Brown, M.D., Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuroscience Statistics Research Laboratory

Study Record Dates

First Submitted

November 23, 2018

First Posted

January 25, 2019

Study Start

March 11, 2021

Primary Completion

March 11, 2021

Study Completion

March 11, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03