Knee Arthroscopy (for Diagnostic or Therapy)Phase 4BUPIPRILO-07NCT01921231
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine
A Phase 4 study testing Hyperbaric Prilocaine 1% and Hyperbaric bupivacaine 0.5% in people with Knee Arthroscopy (for Diagnostic or Therapy) and Inguinal Hernia Repair (Not Urgent), run by Dr. Pere Roura-Poch at 1 site in Spain.
Trial summary
Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroscopy (for Diagnostic or Therapy), Inguinal Hernia Repair (Not Urgent)
- What is being tested?
- Hyperbaric Prilocaine 1% and Hyperbaric bupivacaine 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSpain
- Study dates
- May 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a scheduled knee arthroscopy
- Patients with a scheduled inguinal hernioplasty
Who cannot join
- Patient refusal to regional anesthesia
- American Society of Anesthesiologists score risk equal or greater than 4
- Body mass index greater than 32
- Coagulopathy
- Cutaneous infection at injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.
- Being tested
- Hyperbaric Prilocaine 1%, Hyperbaric bupivacaine 0.5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Prilocaine 1%Drug
Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group.
Hyperbaric bupivacaine 0.5%Drug
Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric prilocaine 1% | Experimental | Solution for injection. Intradural use. In order to obtain Prilocaine 1% we charge a syringe with 2 mL Prilocaine 2%, and we add 1 mL Saline solution (0.9%) and 1 mL Glucose solution (33%). Administer 3 mL of syringe contains in two minutes. Receives: Drug: Hyperbaric Prilocaine 1% |
| Hyperbaric Bupivacaine 0.5% | Active comparator | Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute. Receives: Drug: Hyperbaric bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in post-operative care unit (in minutes)
Time in minutes from closing the surgical incision until to having criteria for discharge to home.
Measured: Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home
Secondary outcomes (4)
Level of motor blocking
Assessed by Bromage score who ranges from Complete block (unable to move feet or knees, score 1) to Able to perform partial knee bend (score 6 who means nil block).
Measured: At surgical incision and at 60 minutes after anesthesia
Fast-track (by-pass recovery area)
Number (and percentage) of patients in each arm that can be transferred directly from the operating room to postsurgical ward. A minimal score of 12 (on modified Aldrete's scoring system with no score <1 in any individual category) would be required for a patient to be fast-tracked.
Measured: Participants will be assessed when surgical incision is closed with surgical staples
Peak sensory block level
The sensory block level was determined pricking dermatomes with a pin from down to up.
Measured: One minute before surgical incision
Transient neurological symptoms
Researchers surveyed if appears pain originated in gluteal region and radiating to both lower extremities following patients by phone.
Measured: At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startMay 2007
- Primary completionMay 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroscopy (for Diagnostic or Therapy)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Pere Roura-Poch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Pere Roura-Poch, Consorci Hospitalari de Vic
- Investigators
- Jordi Serrat-Puyol, MD, Study director, Vic Hospital ConsortiumPere Roura-Poch, MD, MPH, Study chair, Vic Hospital Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921231
- Sponsor's protocol ID
- 2006-006930-17
- Acronym
- BUPIPRILO-07
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine in Knee Arthroscopy and Inguinal Hernia Repair in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT01921231
- Acronym / sponsor ID
- BUPIPRILO-07 / 2006-006930-17
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Dr. Pere Roura-PochUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric prilocaine 1% | Experimental | Drug: Hyperbaric Prilocaine 1%Solution for injection. Intradural use. In order to obtain Prilocaine 1% we charge a syringe with 2 mL Prilocaine 2%, and we add 1 mL Saline solution (0.9%) and 1 mL Glucose solution (33%). Administer 3 mL of syringe contains in two minutes. |
| Hyperbaric Bupivacaine 0.5% | Active comparator | Drug: Hyperbaric bupivacaine 0.5%Solution for injection. Intradural use. Charge a syringe with 1 mL of Bupivacaine (0.5%) and administer it in a minute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a scheduled knee arthroscopy
- Patients with a scheduled inguinal hernioplasty
Key exclusion criteria (5 listed)
- Patient refusal to regional anesthesia
- American Society of Anesthesiologists score risk equal or greater than 4
- Body mass index greater than 32
- Coagulopathy
- Cutaneous infection at injection site
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 |
|---|---|---|
| Hyperbaric Prilocaine 1%Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group. | Drug | Hyperbaric prilocaine 1% |
| Hyperbaric bupivacaine 0.5%Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group. | Drug | Hyperbaric Bupivacaine 0.5% |
Primary outcome
Length of stay in post-operative care unit (in minutes)
Time frame: Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home
Time in minutes from closing the surgical incision until to having criteria for discharge to home.
4 secondary outcomes
Level of motor blocking
Time frame: At surgical incision and at 60 minutes after anesthesia
Fast-track (by-pass recovery area)
Time frame: Participants will be assessed when surgical incision is closed with surgical staples
Peak sensory block level
Time frame: One minute before surgical incision
Transient neurological symptoms
Time frame: At hospital discharge (an average of 8 hours after admission), and at home at 24, 48 and 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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.
Jordi Serrat-Puyol, MD study director
Vic Hospital Consortium
Pere Roura-Poch, MD, MPH study chair
Vic Hospital Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric Prilocaine 1% and Hyperbaric bupivacaine 0.5% in people with Knee Arthroscopy (for Diagnostic or Therapy) and Inguinal Hernia Repair (Not Urgent), run by Dr. Pere Roura-Poch at 1 site 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 2 inclusion and 5 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 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of stay in post-operative care unit (in minutes) (time frame: Participants will be followed an average of 6 hours from surgical incision closure to accomplish discharge criteria to go home). 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 13 Aug 2013.