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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Vitamin E ointment application; Drug: Vaseline ointment application

Study type: Interventional

Funder types: Other

Identifiers

NCT02554123

HRJC15-22

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Vitamin E ointment

Experimental group

Description:

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

Treatment:

Drug: Vitamin E ointment application

Vaseline ointment

Placebo Comparator group

Description:

Vaseline ointment application. Every 12 hours during 7 days.

Treatment:

Drug: Vaseline ointment application