Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids
A single blind, randomized, with blinded evaluation by third parties clinical trial is carried out to assess the analgesic efficay of the addition of morphine chloride to a low dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in the haemorrhoid surgery.
The objective of this clinical trial is to assess if the experimental treatment is as efficacy as the standard treatment in the anesthetic and analgesic effects with less side effects, greater and earlier mobility after surgery and shortened the hospitalization.
|Surgical Remove of Hemorrhoids||Drug: Bupivacaine low dose Drug: Bupivacaine standard dose Drug: Morphine Chloride||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Assessment of the Analgesic Efficacy of Morphine Chloride in Addition to a Low Dose Solution of Spinal Anaesthetic in Hemorrhoidectomy Compared to a Standard Dose of Spinal Local Anaesthetic. Simple Blind, Randomized, With Blinded Evaluation by Third Parties Clinical Trial.|
- Measurement of Time to Start the Anaesthetic Effect [ Time Frame: First 20 minutes between administration and beginning of surgery ]To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.
- Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable. [ Time Frame: Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge ]To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.
- Greater and Earlier Mobilization Measured by Bromage Scale. [ Time Frame: During the first 24 hours after surgery and at the entry and exit of the resuscitation unit ]
To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.
Total Score in the Bromage Scale goes from 1 to 5, where:
1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)
- Number of Adverse Events [ Time Frame: Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge ]To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.
- Time of Hospitalization [ Time Frame: Up to 72 hours after the intervention ]To see if the hospitalization time is shortened or not by the experimental treatment.
|Study Start Date:||March 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Bupivacaine + Morphine Chloride
People in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine.
Drug: Bupivacaine low dose
A dose of morphine chloride added to a low dose solution of bupivacaine administered intraduralDrug: Morphine Chloride
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Active Comparator: Bupivacaine standard dose
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine
Drug: Bupivacaine standard dose
Single intradural standard dose of bupivacaine
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02046772
|Hospital Universitario Principe de Asturias|
|Alcala de Henares, Madrid, Spain, 28805|
|Hospital del Henares|
|Coslada, Madrid, Spain, 28822|
|Principal Investigator:||Manuel Ruiz Castro, MD, PhD||Hospital Universitario Principe de Asturias|