Morphine vs. Oxycodone for Postoperative Pain Management - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital University of Oslo
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00528177

Purpose

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

Condition	Intervention	Phase
Hysterectomy Myoma Postoperative Pain Opioids	Drug: Morphine and oxycodone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 4: A Comparison of Intravenous Administration of Morphine vs. Oxycodone for Postoperative Pain Management Following Laparoscopic Hysterectomy or Myomectomy

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

Dosage relation between oxycodone and morphine. Pain score (VAS). Adverse effects. [ Time Frame: Within the first postoperative day (24 hours). ]

Estimated Enrollment:	90
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
O: Active Comparator 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.
M: Active Comparator 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.

Arms

Assigned Interventions

O: Active Comparator

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.

M: Active Comparator

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.

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

Kalso E. Oxycodone. Journal of Pain & Symptom Management 2005; 29: S47-S56.
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.
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.
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.
Ross FB, Smith MT. The intrinsic antinociceptive effects of oxycodone appear to be kappa-opioid receptor mediated. Pain 1997; 73: 151-7.
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.
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.
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.
Nielsen PR. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand 2007; 51: 582-6.
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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528177

Locations

Norway
Ullevaal University Hospital
Oslo, Norway, 0407

Sponsors and Collaborators

Ullevaal University Hospital

University of Oslo

Investigators

Study Director:

Johan Ræder, Prof.MD,Phd

Ullevaal University Hospital

More Information

No publications provided

Responsible Party:	Ullevaal University Hospital ( Ullevaal University Hospital )
Study ID Numbers:	328-07137 1.2007.1463
Study First Received:	September 11, 2007
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00528177 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Ullevaal University Hospital:

kappa-opioid receptor
my-opioid receptor
oxycodone
morphine
postoperative pain

Study placed in the following topic categories:

Morphine
Signs and Symptoms
Postoperative Complications
Oxycodone
Central Nervous System Depressants
Narcotics

Pain
Peripheral Nervous System Agents
Analgesics
Myoma
Analgesics, Opioid
Pain, Postoperative

Additional relevant MeSH terms:

Morphine
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009