NCT01591382

Brief Summary

Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4 postoperative-pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 22, 2017

Completed
Last Updated

March 22, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

May 1, 2012

Results QC Date

February 1, 2017

Last Update Submit

February 1, 2017

Conditions

Postoperative Pain

Keywords

KetaminePostoperative painOpioid dependent patientsAcute pain control

Outcome Measures

Primary Outcomes (1)

  • Average Postoperative Pain Score

    Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.

    Participants were followed for the duration of hospital stay, an average of approximately 3 days.

Secondary Outcomes (4)

  • Worst Postoperative Pain Score

    Participants were followed for the duration of hospital stay, an average of approximately 3 days.

  • Least Postoperative Pain Score

    Participants were followed for the duration of hospital stay, an average of approximately 3 days.

  • 24-Hour Postoperative Opioid Use

    For 24 hours following surgery

  • Number of Participants With Treatment Related Adverse Events (AEs)

    Participants were followed for the duration of hospital stay, an average of approximately 3 days.

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.

Drug: KetamineDrug: Hydromorphone PCA

Placebo

PLACEBO COMPARATOR

Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).

Drug: PlaceboDrug: Hydromorphone PCA

Interventions

KetamineDRUG

Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.

Ketamine
PlaceboDRUG

Patients who received ketamine-matching placebo were given saline infusions

Placebo
Hydromorphone PCADRUG

Intravenous hydromorphone PCA

KetaminePlacebo

Eligibility Criteria

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

You may qualify if:

  • Chronic pain \> 6 months
  • Long term use of opioids
  • Major surgery

You may not qualify if:

  • Use of regional anesthetic techniques
  • No need for intravenous (IV) patient controlled analgesia (PCA) after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Srdjan S. Nedeljkovic
Organization
Brigham and Women's Hospital
snedeljkovic@partners.org

Study Officials

  • Srdjan S Nedeljkovic, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff, Pain Management Center

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 4, 2012

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

March 22, 2017

Results First Posted

March 22, 2017

Record last verified: 2017-02

Locations

US(1)