NCT04284930

Brief Summary

Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

August 12, 2016

Results QC Date

September 1, 2020

Last Update Submit

December 13, 2020

Conditions

Pain, Postoperative

Keywords

local anesthetic continuous infusion pumplocal injection of Exparel

Outcome Measures

Primary Outcomes (1)

  • Total Narcotic Usage

    Post-op pain measured by total post-op Morphine equivalents

    total hospital stay, an average of 3 days

Study Arms (3)

Depobupivacaine

EXPERIMENTAL

Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.

Drug: Depobupivacaine

OnQ Pump

ACTIVE COMPARATOR

Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.

Drug: OnQ pump

bupivacaine

ACTIVE COMPARATOR

Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.

Drug: 0.25% Bupivacaine

Interventions

DepobupivacaineDRUG

surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.

Also known as: Exparel
Depobupivacaine
OnQ pumpDRUG

group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.

OnQ Pump
0.25% BupivacaineDRUG

group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.

Also known as: Marcaine
bupivacaine

Eligibility Criteria

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

You may qualify if:

  • Non pregnant women
  • age 18 years or older
  • scheduled to have unilateral DIEP flap breast reconstruction.
  • Must have ASA physical status classification of 1,2, or 3

You may not qualify if:

  • concurrent or recent medical condition that could interfere with study participation
  • history of any of the following:
  • hepatitis
  • alcohol/substance abuse
  • uncontrolled psychiatric disorders
  • known allergy/ contraindication to any of the following:
  • amide-type local anesthetics
  • opioids
  • propofol
  • Body weight of less than 50 kg
  • have participated in another study involving an investigational medication with in the past 30 days
  • taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Risal Djohan
Organization
Cleveland Clinic
djohanr@ccf.org
216 312-6146

Study Officials

  • Risal Djohan, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2016

First Posted

February 26, 2020

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 7, 2021

Results First Posted

January 7, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)