Morphine vs. Oxycodone for Postoperative Pain Management
Information source: Ullevaal University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hysterectomy; Myoma; Postoperative Pain; Opioids
Intervention: Morphine and oxycodone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ullevaal University Hospital Official(s) and/or principal investigator(s):
Johan Ræder, Prof.MD,Phd, Study Director, Affiliation: Ullevaal University Hospital
Overall contact:
Harald Lenz, MD, Phone: +4723015427, Ext: +4790549545, Email: harald.lenz@medisin.uio.no
Summary
The purpose of this study is to determine whether oxycodone provides better analgesia
compared to morphine after laparoscopic hysterectomy or myomectomy.
Clinical Details
Official title: Phase 4: A Comparison of Intravenous Administration of Morphine vs. Oxycodone for Postoperative Pain Management Following Laparoscopic Hysterectomy or Myomectomy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Dosage relation between oxycodone and morphine.
Pain score (VAS).
Adverse effects.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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.
Locations and Contacts
Harald Lenz, MD, Phone: +4723015427, Ext: +4790549545, Email: harald.lenz@medisin.uio.no
Ullevaal University Hospital, Oslo 0407, Norway; Recruiting
Harald Lenz, MD, Phone: +4723015427, Email: harald.lenz@medisin.uio.no
Johan Ræder, Prof.MD,PhD, Phone: +4722119690, Email: johan.rader@medisin.uio.no
Additional Information
Starting date: September 2007
Ending date: May 2008
Last updated: September 11, 2007
|
