Multimodal Analgesia for the Reduction of Postoperative O... | NCT03817034

Studies
Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption

NCT03817034

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Apr 1, 2021Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Pain

Interventions

Multimodal analgesia

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We decided to close this study and come up with a new study design.

Expanded Access Info

Not provided

Start Date

Mar 11, 2021Actual

Primary Completion Date

Mar 11, 2021Actual

Completion Date

Mar 11, 2021Actual

First Submitted Date

Nov 23, 2018

First Submission Date that Met QC Criteria

Jan 24, 2019

First Posted Date

Jan 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2021

Last Update Posted Date

Apr 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emery Brown, Director, Neuroscience Statistics Research Laboratory, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

During this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. Data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multimodal Analgesia	Experimental		Drug: Multimodal analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multimodal analgesia	Drug	Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac	Multimodal Analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Emery N Brown, M.D., Ph.D.	Massachusetts General Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided