Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine (PASORII)

November 23, 2016 updated by: mads u werner

Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.

Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.

The objectives are:

  • to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
  • to investigate if these effects are related to the volunteers individual pain sensitivity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Please refer to:

Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 [doi];jpr-6-023 [pii].

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy individuals
  • adequate psychomotor performance to perform pain tests
  • pain-sensitive or pain-nonsensitive according to prespecified criteria

Exclusion Criteria:

  • known allergy to morphine or buprenorphine
  • prior adverse experiences with opioids
  • history of abuse
  • females not taking P-pills
  • skin lesions on the test-sites
  • suffering from chronic pain
  • medication with analgesics
  • BMI > 28
  • smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: morphine low dose
morphine infusion 10 mg over a 210 min period
Drug: morphine LO
intravenous infusion, 10 mg, once, 4 hours
Other Names:
  • Morfin SAD
EXPERIMENTAL: morphine high dose
morphine infusion 20 mg over a 210 min period
Drug: Morphine Hi
intravenous infusion, 20 mg, once, 4 hours
Other Names:
  • Morfin SAD
EXPERIMENTAL: buprenorphine low dose
buprenorphine infusion 0.3 mg over a 210 min period
Drug: Buprenorphine LO
intravenous infusion, 0.3 mg, once, 4 hours
Other Names:
  • Temgesic
EXPERIMENTAL: buprenorphine high dose
buprenorphine infusion 0.6 mg over a 210 min period
Drug: Buprenorphine Hi
intravenous infusion, 0.6 mg, once, 4 hours
Other Names:
  • Temgesic
PLACEBO_COMPARATOR: placebo
placebo (normal saline) infusion 0.6 mg over a 210 min period
Other: saline
intravenous infusion, 0.9% saline, once, 4 hours
Other Names:
  • 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic and antihyperalgesic effects
Time Frame: 0 to 180 min after a first degree burn injury
Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury
0 to 180 min after a first degree burn injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals
Time Frame: 0-180 min after first degree burn injury
The ratios between areas under curve (0-180 min after first degree burn injury) for analgesic effect assessed by change in primary hyperalgesia (pain rating VAS])and antihyperalgesic effect assessed by reduction in area of hyperalgesia (sq. cm).
0-180 min after first degree burn injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

mads u werner

Collaborators

Norpharma A/S

Investigators

  • Study Director: Mads U Werner, MD, DMSc, Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O
  • Study Chair: Lona L Christrup, MSc, PhD, Pharmaceutical Faculty, Copenhagen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (ESTIMATE)

February 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2010-115
  • 2010-022903-23 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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