Topical nifedipine for post haemorrhoidectomy pain relief

Phase 3

Conditions: Pain
Surgery - Other surgery
Haemorrhoidectomy
Anaesthesiology - Pain management

Registration Number: ACTRN12623000514606

Lead Sponsor: Dr Christopher Steen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients over the age of 18 who are planned for 3-column haemorrhoidectomy, by a closed technique, will be recruited by surgeons during either their initial consultation for haemorrhoidectomy surgery or on the day of planned surgery.

Exclusion Criteria

Patients who will not be included in the trial will be those who:
i.are under the age of 18
ii.are pregnant or breast feeding
iii.have concurrent non-haemorrhoidal anorectal disease
iv.have a known allergy to nifedipine
v.have comorbidities or take medications that are a contra-indication to nifedipine usage
vi.have impaired renal function where parecoxib is contra-indicated
vii.have a chronic pain condition requiring ongoing regular analgesia
viii.cannot provide informed consent
ix.cannot have a general anaesthetic

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative pain will be the primary outcome. This will be assessed using a validated 10-point standardised visual analogue scale (VAS). Scores will range from zero (no pain at all) to ten (worst pain imaginable). [ Using the 10-point standardised VAS, pain will be measured at the following timepoints:<br>i.pre-operatively (baseline)<br>ii.recovery (within the first 30 minutes post-operatively)<br>iii.4 hours (discharge) post-operatively<br>iv.24 and 48hours post-operatively<br>v.1 and 4 weeks post-operatively]

Secondary Outcome Measures