Morphine vs. Oxycodone for Postoperative Pain Management

July 3, 2011 updated by: Ullevaal University Hospital

Phase 4: A Comparison of Intravenous Administration of Morphine vs. Oxycodone for Postoperative Pain Management Following Laparoscopic Hysterectomy or Myomectomy

The purpose of this study is to determine whether oxycodone provides better analgesia compared to morphine after laparoscopic hysterectomy or myomectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traditionally, a 1:1 ratio in analgesic potency between intravenous morphine and oxycodone has been presumed (1-2), but one study demonstrated a 3:2 ratio between those drugs (3). During the last years, several studies indicate that oxycodone has the potential of mediating pain relief through the kappa-opioid receptor (4-6), and not only on the my-opioid receptor like most other opioids used in the clinic. Kappa-opioid receptors are widely distributed in visceral organs, and this may explain why Kalso (3) found less need for oxycodone compared to morphine in patients undergoing abdominal surgery.

The aim of this study is to investigate whether patients with visceral postoperative pain need less oxycodone compared to morphine, and whether patients receiving oxycodone experience better pain relief and less adverse effects compared to patients receiving morphine.

Before start of surgery, the patients will be tested with PainMatcher, an instrument testing electrical pain threshold in the skin (7-10), to ensure that both groups have the same pain threshold before surgery.

References

  1. Kalso E. Oxycodone. Journal of Pain & Symptom Management 2005; 29: S47-S56.
  2. Silvasti M, Rosenberg P, Seppala T, Svartling N, Pitkanen M. Comparison of analgesic efficacy of oxycodone and morphine in postoperative intravenous patient-controlled analgesia. Acta Anaesthesiol Scand 1998; 42: 576-80.
  3. Kalso E, Poyhia R, Onnela P, Linko K, Tigerstedt I, Tammisto T. Intravenous morphine and oxycodone for pain after abdominal surgery. Acta Anaesthesiol Scand 1991; 35: 642-6.
  4. Staahl C, Christrup LL, Andersen SD, Arendt-Nielsen L, Drewes AM. A comparative study of oxycodone and morphine in a multi-modal, tissue-differentiated experimental pain model. Pain 2006; 123: 28-36.
  5. Ross FB, Smith MT. The intrinsic antinociceptive effects of oxycodone appear to be kappa-opioid receptor mediated. Pain 1997; 73: 151-7.
  6. Sandner-Kiesling A, Pan HL, Chen SR, James RL, Haven-Hudkins DL, Dewan DM, Eisenach JC. Effect of kappa opioid agonists on visceral nociception induced by uterine cervical distension in rats. Pain 2002; 96: 13-22.
  7. Alstergren P, Forstrom J, Alstergren P, Forstrom J. Acute oral pain intensity and pain threshold assessed by intensity matching to pain induced by electrical stimuli. Journal of Orofacial Pain 2003; 17: 151-9.
  8. Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV. Reliability and responsiveness of three different pain assessments. Journal of Rehabilitation Medicine 2001; 33: 279-83.
  9. Nielsen PR. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand 2007; 51: 582-6.
  10. Stener-Victorin E, Kowalski J, Lundeberg T. A new highly reliable instrument for the assessment of pre- and postoperative gynecological pain. Anesth & Analg 95: 151-7.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • Norway
      • Oslo, Norway, 0407
        • Ullevaal University 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients (American Society of Anaesthesiologists (ASA) I, II and III) due for elective, laparoscopic, non-malignant gynaecologic surgery: Hysterectomy or myomectomy.
  • Written informed consent.
  • Age: 18 to 70 years.

Exclusion Criteria:

  • Patients having used non-steroidal anti-inflammatory drugs (NSAIDs) the last 24 hours.
  • Sensitivity towards the study drugs.
  • Cardiovascular risk conditions: Heart failure, unstable hypertension, coronary artery disease.
  • Patients using opioids, steroids or anti-emetic drugs.
  • Serious mental disease.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: O
This arm will receive intravenous oxycodone at the end of surgery and PCA oxycodone for postoperative pain relief.
Drug: Morphine and oxycodone

At the end of surgery, group 1 will receive intravenous morphine 0.07 mg/kg and intravenous PCA morphine 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. Group 2 will receive intravenous oxycodone 0.07 mg/kg and intravenous PCA oxycodone 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours.

The patients will use the PCA until the next morning.
ACTIVE_COMPARATOR: M
This arm will receive intravenous morphine at the end of surgery and PCA morphine for postoperative pain relief.
Drug: Morphine and oxycodone

At the end of surgery, group 1 will receive intravenous morphine 0.07 mg/kg and intravenous PCA morphine 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours. Group 2 will receive intravenous oxycodone 0.07 mg/kg and intravenous PCA oxycodone 0.015 mg/kg every time they push the botton with 5 minutes lock-out interval. Maximum 16 mg/2 hours.

The patients will use the PCA until the next morning.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dosage relation between oxycodone and morphine. Pain score (VAS). Adverse effects.
Time Frame: Within the first postoperative day (24 hours).
Within the first postoperative day (24 hours).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ullevaal University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 328-07137 1.2007.1463

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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