A comparison of intravenous oxycodone with morphine in day-case laparoscopic gynaecological surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007804-14-IE

Enrollment

Registered

2008-01-11

Start date

2008-06-10

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute post-operative pain MedDRA version: 9.1 Level: LLT Classification code 10066714 Term: Acute pain MedDRA version: 9.1 Level: LLT Classification code 10036286 Term: Post-operative pain

Interventions

Trade Name: OxyNorm Product Name: OxyNorm Pharmaceutical Form: Solution for injection INN or Proposed INN: OXYCODONE HYDROCHLORIDE CAS Number: 124903 Current Sponsor code: oxynorm 1 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I-II patients aged over 18 years under going elective day case operative laparoscopic surgery will be recruited into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with chronic pain states requiring regular opioid analgesia, current nausea and vomiting, known allergies or contraindications to any of the medications used in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: We hypothesize that intravenous oxycodone would provide better post-operative pain control with less side effects of nausea, vomiting, and drowsiness compared to morphine in day case laparoscopic gynaecological surgery. To test this hypothesis, we will carry out a prospective randomized, double-blinded, controlled clinical trial in patients undergoing operative laparoscopic gynaecological surgery with perioperative administration of i.v. oxycodone or i.v. morphine.;Secondary Objective: Patient satisfaction, time to discharge, unwanted opioid related effects will also be recorded. Patients will also be contacted by telephone 24-30 hours after discharge and interviewed by the investigator to ascertain their quality of recovery based on a validated structured questionnaire (QoR-40).;Primary end point(s): Pain (visual analogue scale 0-10) rest and dynamic at 30 minutes, 1, 2, 4 hours and at discharge Time to first rescue analgesia Cumulative opioid consumption Adverse effects associated with opioid administration - (i) Nausea, vomiting (ii) Respiratory depression (iii) pruritus (iv) sedation (v) lack of concentration (VAS 0-10); (vi) headache (VAS 0-10).	—

Measure

Time frame

Main Objective: We hypothesize that intravenous oxycodone would provide better post-operative pain control with less side effects of nausea, vomiting, and drowsiness compared to morphine in day case laparoscopic gynaecological surgery. To test this hypothesis, we will carry out a prospective randomized, double-blinded, controlled clinical trial in patients undergoing operative laparoscopic gynaecological surgery with perioperative administration of i.v. oxycodone or i.v. morphine.;Secondary Objective: Patient satisfaction, time to discharge, unwanted opioid related effects will also be recorded. Patients will also be contacted by telephone 24-30 hours after discharge and interviewed by the investigator to ascertain their quality of recovery based on a validated structured questionnaire (QoR-40).;Primary end point(s): Pain (visual analogue scale 0-10) rest and dynamic at 30 minutes, 1, 2, 4 hours and at discharge Time to first rescue analgesia Cumulative opioid consumption Adverse effects associated with opioid administration - (i) Nausea, vomiting (ii) Respiratory depression (iii) pruritus (iv) sedation (v) lack of concentration (VAS 0-10); (vi) headache (VAS 0-10).

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026