Spinal AnesthesiaNCT02565303
Minimum Effective Dose of Ropivacaine for Spinal Anesthesia for Cesarean Delivery
A study testing Intervertebral space and Ropivacaine in people with Spinal Anesthesia, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4 intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected into subarachnoid space depends on the given dose and the chosen intervertebral space. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Intervertebral space and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2015to 30 Jun 2017
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full term parturient(> 37 and <42 weeks gestation)
- Above 20 years and below 35 years
- American Society of Anesthetists(ASA) I to II
- Singleton pregnancy
- Elective cesarean section
- Body weight during 60-85kg, height during 150-170cm
Who cannot join
- Patient refusal
- Hypertension
- Diabetes mellitus
- Heart diseases
- Asthma
- Abnormal fetus or placenta
- Contraindications to combined spinal-epidural anesthesia(CSEA)
- Allergy to ropivacaine
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 021
About this study
Official title: Minimum Effective Dose of Intrathecal Ropivacaine Required for Cesarean Delivery: A Prospective, Randomized Comparison Between L2-3 and L3-4 Approach
Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4 intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected into subarachnoid space depends on the given dose and the chosen intervertebral space. Appropriate dose could satisfy the requirement of operation and reduce incidence of the adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in cesarean section through the two intervertebral spaces, respectively. This study is being conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in cesarean section.
Read the detailed description
Some unexpected adverse reactions such as respiratory depression, vomiting, especially supine hypotensive syndrome could caused by a high dose of anesthetic in cesarean section. The investigators assumed that there be a minimum effective dose that will be associated with the best possible performance of ropivacaine for different intervertebral spaces(L2-3 and L3-4 in usual). That maybe enhance the comfort of parturient and safety of fetus.
This study is conducted as a prospective, randomized, up-down sequential dose of isobaric ropivacaine in 3 mL that will provide effective analgesia for 50% of parturients in cesarean section. The investigators use the combined spinal-epidural anesthesia(CSEA) technique in the study. The initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group, and the testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group. If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg.
The visual analogue scale (VAS) is used to rate the pain, where 0 is no pain and 10 is the worst pain imaginable. Criteria for evaluation:(1) effective: after spinal anesthesia finish, a dose that provide adequate sensory dermatomal anesthesia to pinprick to T6 or higher within 10 minutes, and the VAS is lower than or equal to 3 within 60minutes after skin incision; (2) ineffective: if the initial plane of sensory dermatomal anesthesia is lower than T6 or VAS is greater than 3 within 60 minutes after skin incision, the dose of ropivacaine is considered inadequate and additional lidocaine is given through epidural catheter.
Motor assessments are performed at the start of operation. Motor block in the lower limb is assessed by a modified Bromage scale (0=no paralysis, 1=unable to raise extended leg, 2=unable to flex knee,3=unable to flex ankle). All of the assessments are made by an anesthetist who is blinded to the group assignment as well as to the dose injected.
On the other hand, the investigators will compare the incidence of adverse reaction between the L2-3 and L3-4 group.
Using the Dixon and Massey up-and-down method study design, 60 patients scheduled for elective cesarean section will be included in the study, 30 for each group.
- Conditions
- Spinal Anesthesia
- Being tested
- Intervertebral space, Ropivacaine
- Keywords
- cesarean delivery, ropivacaine, minimum effective dose, dose-response relationship, intrathecal, intervertebral space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervertebral spaceProcedure or surgery
RopivacaineDrug
Also called Naropin
The initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group with the volume of 3 mL in both groups. The testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group.If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg.
| Study group | Role | What they receive |
|---|---|---|
| L2-3 intervertebral group | Experimental | The initial dose of ropivacaine for subarachnoid is chosen as 12 mg in L2-3 intervertebral space group. Receives: Procedure: Intervertebral space; Drug: Ropivacaine |
| L3-4 intervertebral group | Experimental | The initial dose of ropivacaine for subarachnoid is chosen as 15 mg in L3-4 group. Receives: Procedure: Intervertebral space; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block assessment evaluated with visual analogue scale (VAS) and sensory dermatomal anesthesia
Sensory block assessment will be evaluated with VAS and sensory dermatomal anesthesia. Criteria for evaluation of anesthetic efficacy:(1) effective: within 10 minutes after intrathecal injection, a dose that provides adequate sensory dermatomal anesthesia to pinprick to T6 or higher, and the VAS is lower than or equal to 3 within 60minutes after skin incision; (2) ineffective: the initial plane of sensory dermatomal anesthesia is lower than T6 or VAS is higher than 3 within 60 minutes after skin incision. VAS is a psychometric response scale which can be used in questionnaires. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points, where 0 was no pain and 10 was the worst. A dermatome is an area of skin that is mainly supplied by a single spinal nerve.Usually the upper sensory dermatomal anesthesia is used to assess the effect of intrathecal anesthesia.
Measured: during the entire procedure of operation
Secondary outcomes (1)
motor block accessment
Motor block in the lower limb will be assessed by a modified Bromage scale (0=no paralysis, 1=unable to raise extended leg, 2=unable to flex knee,3=unable to flex ankle) .
Measured: 10minutes after the spinal anesthesia finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start30 Sep 2015
- Primary completion31 May 2017
- Study completion30 Jun 2017
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng WANG, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565303
- Sponsor's protocol ID
- 2015-35-(1)
- Status last verified
- Feb 2018
- First submitted
- 19 Sep 2015
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Dose of Intrathecal Ropivacaine Required for Cesarean Delivery: A Prospective, Randomized Comparison Between L2-3 and L3-4 Approach
- ClinicalTrials.gov ID
- NCT02565303
- Acronym / sponsor ID
- 2015-35-(1)
- Conditions
- Spinal Anesthesia
- Keywords
- cesarean delivery, ropivacaine, minimum effective dose, dose-response relationship, intrathecal, intervertebral space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 1 Oct 2015 (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.
Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4 intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected into subarachnoid space depends on the given dose and the chosen intervertebral space. Appropriate dose could satisfy the requirement of operation and reduce incidence of the adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in cesarean section through the two intervertebral spaces, respectively. This study is being conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in cesarean section.
Detailed description
Some unexpected adverse reactions such as respiratory depression, vomiting, especially supine hypotensive syndrome could caused by a high dose of anesthetic in cesarean section. The investigators assumed that there be a minimum effective dose that will be associated with the best possible performance of ropivacaine for different intervertebral spaces(L2-3 and L3-4 in usual). That maybe enhance the comfort of parturient and safety of fetus.
This study is conducted as a prospective, randomized, up-down sequential dose of isobaric ropivacaine in 3 mL that will provide effective analgesia for 50% of parturients in cesarean section. The investigators use the combined spinal-epidural anesthesia(CSEA) technique in the study. The initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group, and the testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group. If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg.
The visual analogue scale (VAS) is used to rate the pain, where 0 is no pain and 10 is the worst pain imaginable. Criteria for evaluation:(1) effective: after spinal anesthesia finish, a dose that provide adequate sensory dermatomal anesthesia to pinprick to T6 or higher within 10 minutes, and the VAS is lower than or equal to 3 within 60minutes after skin incision; (2) ineffective: if the initial plane of sensory dermatomal anesthesia is lower than T6 or VAS is greater than 3 within 60 minutes after skin incision, the dose of ropivacaine is considered inadequate and additional lidocaine is given through epidural catheter.
Motor assessments are performed at the start of operation. Motor block in the lower limb is assessed by a modified Bromage scale (0=no paralysis, 1=unable to raise extended leg, 2=unable to flex knee,3=unable to flex ankle). All of the assessments are made by an anesthetist who is blinded to the group assignment as well as to the dose injected.
On the other hand, the investigators will compare the incidence of adverse reaction between the L2-3 and L3-4 group.
Using the Dixon and Massey up-and-down method study design, 60 patients scheduled for elective cesarean section will be included in the study, 30 for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L2-3 intervertebral group | Experimental | Procedure: Intervertebral space, Drug: RopivacaineThe initial dose of ropivacaine for subarachnoid is chosen as 12 mg in L2-3 intervertebral space group. |
| L3-4 intervertebral group | Experimental | Procedure: Intervertebral space, Drug: RopivacaineThe initial dose of ropivacaine for subarachnoid is chosen as 15 mg in L3-4 group. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Full term parturient(> 37 and <42 weeks gestation)
- Above 20 years and below 35 years
- American Society of Anesthetists(ASA) I to II
- Singleton pregnancy
- Elective cesarean section
Key exclusion criteria (8 listed)
- Patient refusal
- Hypertension
- Diabetes mellitus
- Heart diseases
- Asthma
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 |
|---|---|---|
| Intervertebral space | Procedure or surgery | L2-3 intervertebral group, L3-4 intervertebral group |
| RopivacaineAlso: NaropinThe initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group with the volume of 3 mL in both groups. The testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group.If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg. | Drug | L2-3 intervertebral group, L3-4 intervertebral group |
Primary outcome
sensory block assessment evaluated with visual analogue scale (VAS) and sensory dermatomal anesthesia
Time frame: during the entire procedure of operation
Sensory block assessment will be evaluated with VAS and sensory dermatomal anesthesia. Criteria for evaluation of anesthetic efficacy:(1) effective: within 10 minutes after intrathecal injection, a dose that provides adequate sensory dermatomal anesthesia to pinprick to T6 or higher, and the VAS is lower than or equal to 3 within 60minutes after skin incision; (2) ineffective: the initial plane of sensory dermatomal anesthesia is lower than T6 or VAS is higher than 3 within 60 minutes after skin incision. VAS is a psychometric response scale which can be used in questionnaires. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points, where 0 was no pain and 10 was the worst. A dermatome is an area of skin that is mainly supplied by a single spinal nerve.Usually the upper sensory dermatomal anesthesia is used to assess the effect of intrathecal anesthesia.
1 secondary outcome
motor block accessment
Time frame: 10minutes after the spinal anesthesia finished
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 1 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervertebral space and Ropivacaine in people with Spinal Anesthesia, run by Shanghai 6th People's Hospital at 1 site in China.
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 8 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 1 Mar 2018. 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 China. 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.
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?
sensory block assessment evaluated with visual analogue scale (VAS) and sensory dermatomal anesthesia (time frame: during the entire procedure of operation). 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 1 Mar 2018.