Reduction of Postoperative Pain After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

Study Overview
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Brief Summary
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A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups: Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed. Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed. Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated.

Detailed Description
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A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups: Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed. Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed. Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated by a blined epidemiology nurse.

Official Title
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Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment

Conditions
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Pain

Intervention / Treatment
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* Drug: Vitamin E ointment application
* Drug: Vaseline ointment application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain). Haemorrhoids grade III and IV The patients sign an Informed Consent Form agreeing their participation in the study. Exclusion Criteria: Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan Haemorrhoids grade I and II Patients with medical or surgical pathologies that do not allow the participation in the study Disability to understand and accept the entry in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E ointment<br>Vitamin E ointment application. Every 12 hours during 7 days. | Drug: Vitamin E ointment application<br>* Vitamin E ointment application. Every 12 hours during 7 days.<br>|
| Placebo Comparator: Vaseline ointment<br>Vaseline ointment application. Every 12 hours during 7 days. | Drug: Vaseline ointment application<br>* Vaseline ointment application. Every 12 hours during 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days | From the first to the 7th postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for morphine rescue | Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay | 24 hours after surgery |