Satisfaction of pain after different pain medication after operative treatment of a broken bone in a limb.

Phase 1

Conditions: Patient satisfaction with pain relief and pain intensity (Numeric Rating Scale) will be investigated.Also to find predictors we will investigate: age, sex, trauma-site, fracture type, AIS score, multi-trauma, mechanism of injury,
MedDRA version: 17.1Level: HLTClassification code 10024956Term: Lower limb fracturesSystem Organ Class: 100000004859
MedDRA version: 19.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
MedDRA version: 19.1Level: LLTClassification code 10033762Term: ParacetamolSystem Organ Class: 100000004848
MedDRA version: 17.1Level: HLTClassification code 10046292Term: Upper limb fracturesSystem Organ Class: 100000004859
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-000680-24-NL

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All adult patients (age > 18) who will undergo surgical treatment for an extremity fracture treated in the Academic Medical Center Amsterdam.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant, breastfeeding or possibly pregnant patients, patients with relevant drug allergies and children will be excluded from study participation
Further exclusion criteria include: 1) another fracture at any site; 2) pathological fractures; 3) inability to fill out questionnaires; 4) polytrauma patients with other significant injuries outside the skeletal system; 5) patients already receiving any form of analgesic prior to injury; 6) liver or renal dysfunction; 7) diagnosed gastric disease; 8) diagnosed constipation 9) patients receiving MAO-inhibitors.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine (differences in) patient satisfaction with pain relief and pain intensity (Numeric Rating Scale).<br><br>;Secondary Objective: The secondary objective is to determine predictors for pain intensity and disability.;Primary end point(s): Pain satisfaction on a Numeric Rating Scale (0-10)<br>Pain intensity on a Numeric Rating Scale(0-10);Timepoint(s) of evaluation of this end point: At post-operative day 1 and at approx. 2 weeks (suture removal).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): age, sex, trauma-site, fracture type, AIS score, multi-trauma, mechanism of injury, treating surgeon, type of surgery and anesthesia, time from injury until treatment, self-efficacy in response to nociception and mood, disability and comorbidity.<br>;Timepoint(s) of evaluation of this end point: Intake and after approximately 2 weeks