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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E ointment application

Drug

Vitamin E ointment application. Every 12 hours during 7 days.

Vaseline ointment application

Drug

Vaseline ointment application. Every 12 hours during 7 days.

Primary outcomes

Postoperative pain

Time frame: From the first to the 7th postoperative days

Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days

Secondary outcomes

Need for morphine rescue

Time frame: 24 hours after surgery

Need for morphine rescue will be quantified in the first 24 hours after surgery during the hospital stay

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 18, 2015
Registry last updated: Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed