Post-surgical pain following abdominal hysterectomy Signs and Symptoms
Conditions
Interventions
Enrolled patients will be randomised, in a double-blind fashion, to receive oral administration of one of four possible treatments:
1. Meloxicam 15 mg/day and acetaminophen 4000 mg/day and gabapentin
Sponsors
Queen's University (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 or older requiring elective abdominal hysterectomy 2. American Society of Anaesthesiologists class 1 or 2 3. Body mass index less than or equal to 35 kg/m^2
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any study drugs 2. Serious organ disease/dysfunction 3. Persistent pre-operative pain 4. Daily intake, or intake 48 hours pre-operatively, of any analgesic 5. Alcohol/substance abuse 6. A major psychiatric disorder 7. A bleeding disorder 8. Peptic ulcer disease 9. Asthma/chronic obstructive pulmonary disease (COPD) 10. A seizure disorder 11. Any language barrier to communicating with research staff 12. Aged over 80 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough-evoked pain intensity, recorded on the day of surgery and post-operative days one and two. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity at rest, during sitting, and with forced expiration 2. Retrospective measure of average nocturnal pain intensity from 10 pm (previous day) to 8 am (current morning) recorded at 8 am on post-operative days 1 and 2 3. Peak expiratory flow rate, forced vital capacity, forced expiratory volume over one second 4. Total opioid consumption (fentanyl on day of surgery, morphine [nurse-administered and patient-controlled] on day of surgery and post-operative days 1 and 2) 5. Time to fulfilment of post-anaesthetic care unit discharge criteria 6. Presence and severity (mild, moderate or severe) of 12 opioid-related symptoms (evaluated by open-ended questioning): nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness or difficulty staying awake, feeling light-headed or dizzy, feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache 7. Other side effects and their severity (mild, moderate or severe) 8. Time to bladder extubation; time to first urination after bladder catheter removal; time to first bowel movement 9. Timed 'up and go' test 10. Blinding questionnaires 11. Modified Brief Pain Inventory 12. Time to discharge from hospital, time to return to regular activities and return to work (in those working outside of the home) 13. 30-day post-operative surgical pain intensity (present rest pain, present cough pain and worst pain in past week) Recorded on the day of surgery and post-operative days one and two. On post-operative day 30, only pain and major adverse events will be recorded. | — |
Countries
Canada
Outcome results
None listed