Surgical Remove of HemorrhoidsPhase 4NCT02046772
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 Phase 4 study testing Bupivacaine low dose, Bupivacaine standard dose and Morphine Chloride in people with Surgical Remove of Hemorrhoids, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Surgical Remove of Hemorrhoids
- What is being tested?
- Bupivacaine low dose, Bupivacaine standard dose and Morphine Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital del Henares
Coslada, Madrid, 28822
About this study
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.
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.
Read the detailed description
DESIGN OF THE TRIAL:
A multicentre, randomized, single-blind, with masked evaluationby third parties clinical trial.
The Clinical Pharmacology Unit will perform a permuted blocks randomization scheme for each of the two hospitals participating in the trial. The result of this randomization will be kept in this unit and will not be accessible to investigators. Investigators will receive a series of opaque sealed envelopes with a number corresponding to the order of entry of the patients into the trial. When the patient is in the operating room, investigators must open the envelope which contains the group of treatment assigned to that patient. The patient will not know in which intervention group is included. Investigator who performs the spinal puncture and investigator who collects the data and performs the evaluation will no be the same person. This will allow a blind evaluation.
OBJECTIVES:
Main objective:
To evaluate whether the addition of morphine chloride to a low dose solution of local intradural anaesthetic in patients undergoing hemorrhoids surgery produces an anaesthetic efficacy comparable to that produced by a standard dose of local intradural anaesthetic and an improvement of postoperative analgesic efficacy.
Secondary objectives:
- Earlier mobilization of the patient.
- Minor adverse effects.
- A shorter hospital stay of the patient.
TREATMENTS:
Two groups of treatment will be formed, experimental and comparator. The experimental group will receive 3mg of Bupivacaine with addition of 50 micrograms of Morphine Chloride.
The comparator group will receive 5 mg of Bupivacaine.
RESCUE TREATMENTS
If necessary before surgery, midazolam will be administered from 0.02 to 0.05 mg / kg intravenous (IV) depending on clinical response and after the patient is set in the surgical position, if necessary, an intravenous infusion of propofol will be administered at 0.5 - 2mg / kg / h. Sedative drugs with analgesic effects as opioids, ketamine, etc, will be avoided to not interfere with the main analgesic study assessment.
After surgery and during the hospitalization stay the rescue analgesia treatment will be administered only on demand. The rescue treatment allowed by protocol will be an intravenous administration of dexketoprofen up to 50 mg / 8 h and if insufficient, a rescue of 3 mg of morphine chloride will be administered. If morphine chloride is received, these patients will be recorded in the case report forms as inefficacy of the treatment. At home, after discharge, patients will receive rescue analgesia with capsules of dexketoprofen 25 mg / 8 h. (up to 75 mg a day).
SAMPLE SIZE:
66 patients ( 33 patients in the experimental group and 33 patients in the control group)
EFFICACY ASSESSMENT
Pain will be assessed using a visual analog scale (VAS from 0 to 10) at the beginning and end of surgery, at the arrival of resuscitation unit, after 10 and 30 minutes after arrival, during hospitalization stay out of the resuscitation unit and daily at home after discharge.
Doses required of rescue analgesia and hospitalization time will be recorded.
SAFETY ASSESSMENT
Basic monitoring as usual will be perfomed in the surgery room. Motor blockage will be assessed using the modified Bromage scale as follows: 1 = complete motor blocking, 2 = able to move feet only, 3 = patient move the feet and bend the knee, 4 = straight leg raises <30 ° or > 30 ° but not against resistance, 5 = lifts leg> 30 ° against resistance. This measure will be made after surgery in the surgery room and at the arrival and at one hour after resuscitation unit admission.
All the Adverse events will be reported.
- Conditions
- Surgical Remove of Hemorrhoids
- Being tested
- Bupivacaine low dose, Bupivacaine standard dose, Morphine Chloride
- Keywords
- hemorrhoidectomy, analgesia, anaesthetic, bupivacaine, morphine chloride
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine low doseDrug
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
Bupivacaine standard doseDrug
Single intradural standard dose of bupivacaine
Morphine ChlorideDrug
A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine + Morphine Chloride | Experimental | People in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine. Receives: Drug: Bupivacaine low dose; Drug: Morphine Chloride |
| Bupivacaine standard dose | Active comparator | People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine Receives: Drug: Bupivacaine standard dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Time to Start the Anaesthetic Effect
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.
Measured: First 20 minutes between administration and beginning of surgery
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.
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.
Measured: Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge
Secondary outcomes (3)
Greater and Earlier Mobilization Measured by Bromage Scale.
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)
Measured: During the first 24 hours after surgery and at the entry and exit of the resuscitation unit
Number of Adverse Events
To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.
Measured: Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge
Time of Hospitalization
To see if the hospitalization time is shortened or not by the experimental treatment.
Measured: Up to 72 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Remove of HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Agency of Medicines and Health Products, Spanish Health Ministry
- Responsible party
- Sponsor
- Investigators
- Manuel Ruiz Castro, MD, PhD, Principal investigator, Hospital Universitario Principe de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046772
- Sponsor's protocol ID
- HUPA-EC-01-2012
- Other IDs
- 2012-000110-11
- Status last verified
- Aug 2014
- First submitted
- 22 Jan 2014
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02046772
- Acronym / sponsor ID
- HUPA-EC-01-2012
- Conditions
- Surgical Remove of Hemorrhoids
- Keywords
- hemorrhoidectomy, analgesia, anaesthetic, bupivacaine, morphine chloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de AsturiasUniversity, hospital or other
- Collaborators
- Spanish Agency of Medicines and Health Products, Spanish Health Ministry
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 1 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DESIGN OF THE TRIAL:
A multicentre, randomized, single-blind, with masked evaluationby third parties clinical trial.
The Clinical Pharmacology Unit will perform a permuted blocks randomization scheme for each of the two hospitals participating in the trial. The result of this randomization will be kept in this unit and will not be accessible to investigators. Investigators will receive a series of opaque sealed envelopes with a number corresponding to the order of entry of the patients into the trial. When the patient is in the operating room, investigators must open the envelope which contains the group of treatment assigned to that patient. The patient will not know in which intervention group is included. Investigator who performs the spinal puncture and investigator who collects the data and performs the evaluation will no be the same person. This will allow a blind evaluation.
OBJECTIVES:
Main objective:
To evaluate whether the addition of morphine chloride to a low dose solution of local intradural anaesthetic in patients undergoing hemorrhoids surgery produces an anaesthetic efficacy comparable to that produced by a standard dose of local intradural anaesthetic and an improvement of postoperative analgesic efficacy.
Secondary objectives:
- Earlier mobilization of the patient.
- Minor adverse effects.
- A shorter hospital stay of the patient.
TREATMENTS:
Two groups of treatment will be formed, experimental and comparator. The experimental group will receive 3mg of Bupivacaine with addition of 50 micrograms of Morphine Chloride.
The comparator group will receive 5 mg of Bupivacaine.
RESCUE TREATMENTS
If necessary before surgery, midazolam will be administered from 0.02 to 0.05 mg / kg intravenous (IV) depending on clinical response and after the patient is set in the surgical position, if necessary, an intravenous infusion of propofol will be administered at 0.5 - 2mg / kg / h. Sedative drugs with analgesic effects as opioids, ketamine, etc, will be avoided to not interfere with the main analgesic study assessment.
After surgery and during the hospitalization stay the rescue analgesia treatment will be administered only on demand. The rescue treatment allowed by protocol will be an intravenous administration of dexketoprofen up to 50 mg / 8 h and if insufficient, a rescue of 3 mg of morphine chloride will be administered. If morphine chloride is received, these patients will be recorded in the case report forms as inefficacy of the treatment. At home, after discharge, patients will receive rescue analgesia with capsules of dexketoprofen 25 mg / 8 h. (up to 75 mg a day).
SAMPLE SIZE:
66 patients ( 33 patients in the experimental group and 33 patients in the control group)
EFFICACY ASSESSMENT
Pain will be assessed using a visual analog scale (VAS from 0 to 10) at the beginning and end of surgery, at the arrival of resuscitation unit, after 10 and 30 minutes after arrival, during hospitalization stay out of the resuscitation unit and daily at home after discharge.
Doses required of rescue analgesia and hospitalization time will be recorded.
SAFETY ASSESSMENT
Basic monitoring as usual will be perfomed in the surgery room. Motor blockage will be assessed using the modified Bromage scale as follows: 1 = complete motor blocking, 2 = able to move feet only, 3 = patient move the feet and bend the knee, 4 = straight leg raises <30 ° or > 30 ° but not against resistance, 5 = lifts leg> 30 ° against resistance. This measure will be made after surgery in the surgery room and at the arrival and at one hour after resuscitation unit admission.
All the Adverse events will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine + Morphine Chloride | Experimental | Drug: Bupivacaine low dose, Drug: Morphine ChloridePeople in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine. |
| Bupivacaine standard dose | Active comparator | Drug: Bupivacaine standard dosePeople in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients undergoing hemorrhoidectomy.
- Age between 18 and 64.
- Both gender
- ASA I to III.
- With indication for spinal block.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine low doseA dose of morphine chloride added to a low dose solution of bupivacaine administered intradural | Drug | Bupivacaine + Morphine Chloride |
| Bupivacaine standard doseSingle intradural standard dose of bupivacaine | Drug | Bupivacaine standard dose |
| Morphine ChlorideA dose of morphine chloride added to a low dose solution of bupivacaine administered intradural | Drug | Bupivacaine + Morphine Chloride |
Primary outcome
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.
3 secondary outcomes
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
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
Time of Hospitalization
Time frame: Up to 72 hours after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Ruiz Castro, MD, PhD principal investigator
Hospital Universitario Principe de Asturias
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine low dose, Bupivacaine standard dose and Morphine Chloride in people with Surgical Remove of Hemorrhoids, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Time to Start the Anaesthetic Effect (time frame: First 20 minutes between administration and beginning of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.