Post-haemorrhoidectomy Pain and Metronidazole Trial

Not Applicable

Completed

• Conditions: Haemorrhoids; Post-haemorrhoidectomy pain; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Anaesthesiology - Pain management

• Registration Number: ACTRN12619000735156
• Lead Sponsor: Bruce Wilkie

Brief Summary

Of 88 patients enrolled in the study, forty patients (19 placebo patients, 21 metronidazole patients) completed the trial and returned the survey questionnaire (45.5%). There were no differences between groups with regards to age, gender, smoking status, self-reported general health, self-reported general quality of life, haemorrhoid-related pain, haemorrhoid-related impact on quality of life, surgery received (Milligan-Morgan or Ferguson technique), treating surgeon, rate of surgical complications, satisfaction with surgery, experience of surgery, median overall pain score, overall impression of pain control, and likelihood of recommending surgery to other patients. With regards to reported worst pain scores, differences were seen between groups on days 16 and 18-21 with the metronidazole group reporting less pain. Defaecation-related pain followed a similar pattern with the metronidazole group reporting less pain on days 16, 18 and 19. Multilevel mixed effects modelling was utilised to determine whether the interaction of time with treatment allocation was relevant. Using this method of analysis, the impact of time on median worst pain score was identified to more important that treatment allocation, i.e. being prescribed placebo versus metronidazole did not affect the improvement in patients’ reported pain.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-31
• Study Start: 2019-05-16
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Males and females between 18-70 years of age undergoing elective haemorrhoidectomy and able to provide voluntary consent for the procedure and to participate in the trial.

Exclusion Criteria

Renal impairment (eGFR <50, severe ischemic heart disease, active peptic ulcer disease, alcoholism and IV opiate dependency, severe aspirin-sensitive asthma, pregnant women, institutionalised patients, patients unable to provide consent, patients with chronic pain conditions, hypersensitivity or known intolerance to metronidazole, NSAIDs or oxycodone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily pain scores for 21 days on a numerical rating scale[Day of operation to 21 days post-operatively]

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction with surgery via satisfaction survey at routine post-operative follow-up appointment<br><br>Satisfaction was measured on a 7-point scale from very dissatisfied, dissatisfied, slightly dissatisfied, not sure, slightly satisfied, satisfied to very satisfied. This scale was modified from a previous study examining surgical satisfaction post-haemorrhoidectomy. [4 weeks post-operatively];Surgical complications via study specific questionnaire, clinical examination at routine post-operative follow-up appointment and medical records<br><br>Complications include bleeding, infection, urinary retention, faecal incontinence or constipation, anal canal stenosis[Up to 4 weeks post-operatively];Medication related side-effects study specific questionnaire, patient history at routine post-operative follow-up appointment and medical records<br><br>Possible side-effects abdominal discomfort, nausea, vomiting, headache, rash or itch[Up to 4 weeks post-operatively]