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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554123
• Other study ID #: HRJC15-22
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2015
• Last updated: September 17, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Vitamin E ointment application
Vitamin E ointment application. Every 12 hours during 7 days.
• Vaseline ointment application
Vaseline ointment application. Every 12 hours during 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No