Phase 4
N=63
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
Surgical Remove of Hemorrhoids
Bottom Line
View on ClinicalTrials.gov: NCT02046772 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Measurement of Time to Start the Anaesthetic Effect — 2.1; 1.6; 7.7; 4.7 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine low dose (Drug); Bupivacaine standard dose (Drug); Morphine Chloride (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Time to Start the Anaesthetic Effect |
2.1; 1.6; 7.7; 4.7 | — |
| PRIMARY 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. |
0.03; 0.15; 0; 0.3; 0.06; 0.72 | — |
| SECONDARY Greater and Earlier Mobilization Measured by Bromage Scale. |
4; 3.7; 4.1; 3.8; 4.7; 4.8 | — |
| SECONDARY Number of Adverse Events |
2; 0; 7; 3; 0; 1 | — |
| SECONDARY Time of Hospitalization |
26; 30; 3; 2; 1; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing hemorrhoidectomy.
- Age between 18 and 64.
- Both gender
- ASA I to III.
- With indication for spinal block.
- People capable to grant the informed consent.
Exclusion Criteria
- Patients with allergies to the study drugs.
- Patients with any contraindication for performing a spinal technique (coagulation disorders, fever, intracraneal hypertension, abscess in the puncture site, etc..).
- Patients with previous neurological disorders.
- Pregnant women.
- Women who may be pregnant and do not have a negative pregnancy test.
- Breastfeeding women.
- Patients with uncapable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT02046772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.