Patients suffering hemorrhoids which are diagnosed as grade III or IV and proposed to surgical treatment by a Milligan and Morgan procedure MedDRA version: 18.0 Level: LLT Classification code 10019611 Term: Hemorrhoids System Organ Class: 100000004856
Conditions
Interventions
Trade Name: INIBSACAIN HIPERBARICA0.5% solución inyectable
Product Name: Bupivacaina
Product Code: 3349
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BUPIVACAINE
CAS Number: 2180-9
Sponsors
Hospital General de Vic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients suffering hemorrhoids which are diagnosed as grade III or IV and proposed to surgical treatment by a Milligan and Morgan procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients with relapse of their hemorrhoidal disease, Patients proposed for reoperation, Second time hemorrhoidectomies, Rubber band hemorrhoidectomy, Hemorrhoidectomy with Longo technique, Patients with anal fistula, anal fissure or anal polyp, Patients for surgical revision of the anal canal for proctalgia or anusalgia, Patients with neuropathy, Patients with bleeding disorder, Patients with known allergies to medications used (anesthetics and analgesics) and Patients with chronic opioid therapy and chronic treatment with corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Management and control of post-surgical pain in Milligan and Morgan surgical procedure to treat grade III and IV hemorrhoids;Secondary Objective: Analyze the use of analgesia, the length of hospital stay, immediate postoperative complications such as bleeding, and time to heal.;Primary end point(s): Level of pain at several time-points during hospital stay;Timepoint(s) of evaluation of this end point: On first 24 hours, at 1, 6, 12, 18 and 24 hours and from 25 hours to 4 days 3 times a day. At each of these time-points we collect the level of pain by the means an analogic visual scale (from zero to ten points) and with a verbal scale (no pain, mild, moderate, severe). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Drug administration under analgesia protocol and needs of rescue.;Timepoint(s) of evaluation of this end point: When analgesia will be administered under clinical guidelines and the date and hour when a rescue would be be administered (drug and dose), if needed. | — |
Countries
Spain
Contacts
Public ContactPere Roura-Poch
Hospital General de Vic
Outcome results
None listed