Pain management after operative treatment of extremity fractures, a randomized clinical trial

Fracture patients are prescribed a spectrum of analgesics to reduce pain. The
conscious understanding of this pain may be altered by a variety of factors,
including psychosocial factors. This could explain the apparent differences in
prescription habits for analgesic drugs, between American and Dutch orthopaedic
surgeons. There is currently no official post-operative protocol for
pain-management after extremity fractures. The large differences between the
two countries emphasize how much there is to learn in this area of
investigation.
In this project we will study the effects of two different frequently used
analgesic regimens on pain relief, satisfaction with pain relief, and
disability after skeletal trauma. This study will compare a step
1-(acetaminophen (paracetamol)) with a step 2-based (tramadol) regimen. Current
best evidence shows that it is highly possible that fracture patients nowadays
receive more and stronger painkillers than needed. This study will be mandatory
to provide a protocol for pain-management after extremity fractures.
In addition to drug management, it would be helpful to find predictors for pain
intensity and disability to aid the physician in clinical decision-making and
assessing further management.

The primary objective of this study is to determine (differences in) patient
satisfaction with pain relief and pain intensity (Numeric Rating Scale) using a
step 1 vs. a step 2 based analgesic regimen.
The secondary objective is to determine predictors of pain intensity and
disability.
This will be mandatory to develop a useful protocol for pain-management.

This study is designed as a randomized clinical trial with short follow-up (2
weeks). Patients will be randomly assigned to either an acetaminophen based
pain regimen, or a tramadol based regimen. We will measure self-efficacy in
response to nociception and mood at enrollment. At time of suture removal
(approx. 2 weeks) all patients will be given a questionnaire. They are asked to
rate their overall worst and average pain, the level of pain that would be
acceptable to them, overall satisfaction with pain relief (Numeric Rating
Scale), and disability. In addition, we will use a database to record 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, and comorbidity.
Intake will be *as needed* based, with a daily upper limit intake of: 1)
acetaminophen (4x 1g) 2) tramadol (4x 50-100mg). In addition to their
pre-assigned regimen, patients may receive i.m./s.c. morfine as rescue
medication.

Group 1: paracetamol max 1gr per day 'on demand' for a maximum of two weeks.
Group 2: tramadol max 150-300 mg per day 'on demand' for a maximum of two
weeks.

This study does not provide immediate advantage for the participating patient.
For future patients however this study is beneficial, as it will evaluate the
effectiveness of the current pain management after surgical treatment after
extremity fractures. Current evidence suggests that these patients nowadays
might be over treated. Furthermore, this study will likely reduce health costs.
Participation in this study is of low risk, since the patients will not receive
more medication then usual and can use rescue medication if they are
undertreated. We don*t expect this to happen very often since each subject will
receive a frequently used regimen. In addition, our previous prospective study
showed adequate pain levels for patients who received step 1 (WHO pain ladder)
medication.