Spinal AnesthesiaPhase 4NCT03805503
Chloroprocaine for Inguinal Herniorrhaphy
A Phase 4 study testing Chloroprocaine 1% Injectable Solution in people with Spinal Anesthesia, run by University Hospital, Ghent.
Trial summary
This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Chloroprocaine 1% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2015to 4 Dec 2018
- 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
- Outpatients for unilateral inguinal hernia repair
- ASA I - II - III
Who cannot join
- hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
- contraindications to spinal or epidural anesthesia
- bilateral inguinal herniorrhaphy
- extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)
About this study
Official title: Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
Read the detailed description
A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.
The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.
- Conditions
- Spinal Anesthesia
- Being tested
- Chloroprocaine 1% Injectable Solution
- Keywords
- Chloroprocaine, spinal anesthesia, one-day clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine 1% Injectable SolutionDrug
Also called chloroprocaine 3%
standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg.
Efficacy of the analgesia will be evaluated:
Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia.
Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed.
| Study group | Role | What they receive |
|---|---|---|
| chloroprocaine 1% injectable solution | Experimental | Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%.
An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study.
An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study. Receives: Drug: Chloroprocaine 1% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery
Measured: start of surgery
Secondary outcomes (7)
Peak block height
highest sensible block
Measured: during surgery
Time for regression of two segments
Time for regression of two segments
Measured: during surgery
Ambulation time
motor recovery
Measured: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
Time to micturition
Time to micturition
Measured: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
Measured: perioperative
Time to discharge
Time to discharge
Measured: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
Patient satisfaction with anesthesia method: questionnaire
Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
Measured: postoperatively,at moment of hospital discharge measured up to 6 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 posted15 Jan 2019
- Study start16 Sep 2015
- Primary completion7 Sep 2017
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Intervention model
- Sequential
- Model description
- Prospective, up-down sequential allocation
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aliaksandra Parashchanka, MD, Principal investigator, stafmember department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805503
- Sponsor's protocol ID
- EC/2014/1264
- Status last verified
- Jan 2019
- First submitted
- 4 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT03805503
- Acronym / sponsor ID
- EC/2014/1264
- Conditions
- Spinal Anesthesia
- Keywords
- Chloroprocaine, spinal anesthesia, one-day clinic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- 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.
This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
Detailed description
A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.
The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, up-down sequential allocation
| Arm | Type | Receives |
|---|---|---|
| chloroprocaine 1% injectable solution | Experimental | Drug: Chloroprocaine 1% Injectable SolutionProspective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%. An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study. An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients for unilateral inguinal hernia repair
- ASA I - II - III
Key exclusion criteria (4 listed)
- hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
- contraindications to spinal or epidural anesthesia
- bilateral inguinal herniorrhaphy
- extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)
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 |
|---|---|---|
| Chloroprocaine 1% Injectable SolutionAlso: chloroprocaine 3%standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg. Efficacy of the analgesia will be evaluated: Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed. | Drug | chloroprocaine 1% injectable solution |
Primary outcome
The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
Time frame: start of surgery
MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery
7 secondary outcomes
Peak block height
Time frame: during surgery
Time for regression of two segments
Time frame: during surgery
Ambulation time
Time frame: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
Time to micturition
Time frame: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
Time frame: perioperative
Time to discharge
Time frame: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
Patient satisfaction with anesthesia method: questionnaire
Time frame: postoperatively,at moment of hospital discharge measured up to 6 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 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Aliaksandra Parashchanka, MD principal investigator
stafmember department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroprocaine 1% Injectable Solution in people with Spinal Anesthesia, run by University Hospital, Ghent.
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 4 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 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome (time frame: start of surgery). 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 Jan 2019.