acute post-operative peripheral neuropathic pain
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form:
Sponsors
Helse Bergen HF
Eligibility
Inclusion criteria
Inclusion criteria: Age: Participant must be 18 years of age inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics: Patients that have verified NeP following surgery and are identified and included within 7 days after nerve injury Informed Consent: Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 1. Psychiatric disease 2. Renal failure (GFR <60) 3. Patients that are cognitively impaired 4. Daily substance abuse (drugs/alchohol) 5. Pregnancy Prior/Concomitant Therapy: 1. Patients that use current 1st line NeP-medication at admission, regardless of indication. This includes Lyrica, gabapentin, SNRI and Tricyclic antidepressiva.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Investigate the effect of adding pregabalin to the current standard pain treatment for patients with acute NeP. •To characterize the development of acute neuropathic pain in the patients included in the study. ;Secondary Objective: •Investigate whether adding pregabalin will reduce the need for opioids in patients with acute NeP. ;Primary end point(s): •Pain intensity measured using Numeric Rating Scale (NRS), measured 3 times/day (actual pain) ((at 09:00 hrs (+/- 1 h), 15:00 hrs (+/-1h) and 21:00 hrs(+/- 1h)) during the first 2 weeks and then 1 time/week (usual pain for the last 7 days recorded each Monday at 12:00 hrs (+/- 1h)) during the following 10 weeks. NRS will be recorded for both rest and activity. •As this a pilot study, we will describe each individual patient in detail with regards to how long and how intense the pain is rated during the observation period. The number of included patients will probably not be sufficient to produce results of statistical significance between the pregabalin group and the control group. However, the detailed history of each patient will give new insight which will serve as a basis for later possible RCTs. ;Timepoint(s) of evaluation of this end point: See above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Opioid use during the study period using oral morphine equivalents (OMEQ) as measurement. Opioid use will be assessed and recorded at the follow-up visit. . ;Timepoint(s) of evaluation of this end point: follow-up visit, after end of study | — |
Countries
Norway
Contacts
Public ContactLars Jørgen Rygh
Helse Bergen HF
Outcome results
None listed