Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

NCT ID: NCT02152592

Last Updated: 2014-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief Summary

the primary objective of this study is to assess and compare the efficacy, safety and benefits of Controlled Release (CR) oxycodone/paracetamol with our current pain protocol (paracetamol/naproxen) in the treatment of acute postoperative pain at home after painful day-case surgery. We hypothesize that ambulatory patients postoperatively treated with oxycodone/paracetamol will achieve better pain relief with equal side effects compared to patients treated with paracetamol/naproxen.

Our second goal is to assess analgesic adherence in the outpatient setting.

Endpoints:

Primary endpoints: pain intensity (Visual analogue scale) Secondary endpoints: - side-effects/ adverse effects of study medication

• patient satisfaction with pain treatment
• compliance to study medication

Study design:

Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or laparoscopic inguinal hernia repair) will be enrolled in an open randomized controlled trial (RCT) at our pre-assessment clinic.

Subjects will be enrolled by a study nurse and will be randomized into one of three study treatment groups using a computer-generated list. Patients in group 1 (PCM/NAPR) are assigned to postoperative analgesia using naproxen 500 mg orally twice a day for 48 hours postoperatively. Patients assigned to group 2 (PCM/Oxy1) receive CR oxycodone 10 mg orally twice a day for 24 hours. Patients in group 3 (PCM/Oxy2) are postoperatively treated witch CR oxycodone 10 mg orally twice a day for 48 hours. All patients also receive paracetamol 1000 mg orally four times a day for 48 hours postoperatively.

Recovery after discharge will be assessed using a diary for up to 48 hours after surgery. Three times a day, patients have to rate pain at rest and movement (VAS), fatigue, nausea, vomiting, pruritus, miction problems, pyrosis, and abdominal complaints. Furthermore, compliance to the use of the study medication will be assessed by checking whether the patients took the study medication as prescribed and if any other pain medication was used. Compliance will be assessed three times a day and patients will be divided into three groups according to medication use: always = full compliance, sometimes = partial compliance, or never = no compliance.

Finally, overall satisfaction with the postoperative pain treatment will be assessed (score 0-10).

Conditions

Postoperative Pain After Ambulatory Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCM/NAPR group

paracetamol 1000 mg orally four times a day for 48 hours postoperatively and naproxen 500 mg orally twice a day for 48 hours postoperatively (standard hospital pain protocol for treatment of acute postoperative pain at home after painful day-case surgery)

Group Type: NO_INTERVENTION

No interventions assigned to this group

PCM/Oxy1 group

Controlled Release oxycodone 10 mg orally twice a day for 24 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively

Group Type: ACTIVE_COMPARATOR

PCM/Oxy1

Intervention Type: DRUG

Controlled Release oxycodone 10 mg orally twice a day for 24 hours

PCM/Oxy2 group

CR oxycodone 10 mg orally twice a day for 48 hours and paracetamol 1000 mg orally four times a day for 48 hours postoperatively

Group Type: ACTIVE_COMPARATOR

PCM/Oxy2

Intervention Type: DRUG

CR oxycodone 10 mg orally twice a day for 48 hours

Interventions

PCM/Oxy1

Controlled Release oxycodone 10 mg orally twice a day for 24 hours

Intervention Type: DRUG

PCM/Oxy2

CR oxycodone 10 mg orally twice a day for 48 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for painful ambulatory surgery (knee arthroscopy, unilateral open or laparoscopic inguinal hernia repair)
• American Society of Anesthesiologists (ASA) physical classification I or II

Exclusion Criteria

• cognitive impairment,
• preoperative pharmacologic pain treatment
• allergy to or a contraindication for taking the study medication (e.g. paracetamol, oxycodone, naproxen or another NSAID)
• porphyria
• pregnancy or lactation
• history of severe renal, hepatic, pulmonary, or cardiac failure
• current symptoms or history of gastrointestinal bleeding, ileus or chronic obstipation
• history of substance abuse, or use of medication with a suppressive effect on the central nervous system

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bjorn Stessel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology, Maastricht University Medical Center+, The Netherlands

Maastricht, , Netherlands

Countries

Netherlands

References

Stessel B, Theunissen M, Fiddelers AA, Joosten EA, Kessels AG, Gramke HF, Marcus MA. Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial. Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.

Reference Type: DERIVED

PMID: 25516773 (View on PubMed)

Other Identifiers

2006-003545-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11524

Identifier Type: -

Identifier Source: org_study_id