PainPhase 4OLAANCT02036242
Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia
A Phase 4 study testing Sole local anesthetic, Sufentanil (Opioid plus local anesthetic) and Ropivacaine in people with Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Sole local anesthetic, Sufentanil (Opioid plus local anesthetic) and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Feb 2014
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparas
- Request epidural analgesia
- Chinese
Who cannot join
- Allergic to opioid or local anesthetics
- Fail to perform epidural puncture and catheterization
- Organ dysfunction
- Contraindications for epidural anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
- Conditions
- Pain
- Being tested
- Sole local anesthetic, Sufentanil (Opioid plus local anesthetic), Ropivacaine
- Keywords
- Opioid, Local anesthetic, Labor delivery, Safety
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sole local anestheticDrug
Also called Ropivacaine, Naropin
0.125% ropivacaine 10-15 ml every 1h during labor delivery
Sufentanil (Opioid plus local anesthetic)Drug
Also called Naropin
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sole local anesthetic | Experimental | Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently Receives: Drug: Sole local anesthetic; Drug: Ropivacaine |
| Opioid plus local anesthetic | Active comparator | Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently Receives: Drug: Sufentanil (Opioid plus local anesthetic); Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scorings
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: up to 3 days
Secondary outcomes (12)
Pruritus
Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Dizziness
Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Nausea
Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Vomiting
Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Drowsiness
Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Sedation
Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Respiratory depression
Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Psychological effects
Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Myoclonus
This describes muscle rigidity and abnormal movement of the limbs and muscles.
Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Maternal heart rate
Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Miosis
Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
Measured: From post-randomization to post-delivery day 3
Cesarean section
Record the incidence of Cesarean section after completion of the labor delivery.
Measured: The time at the end of the labor delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Zhou Wang, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036242
- Sponsor's protocol ID
- NJFY13007
- Other IDs
- JQX12009
- Acronym
- OLAA
- Status last verified
- Feb 2014
- First submitted
- 11 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Xu S, Qin X, Li X, Feng SW, Liu Y, Wang W, Guo X, Shen R, Shen X, Wang F. Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia. Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882.
PubMed 26512604
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
- ClinicalTrials.gov ID
- NCT02036242
- Acronym / sponsor ID
- OLAA / NJFY13007
- Conditions
- Pain
- Keywords
- Opioid, Local anesthetic, Labor delivery, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Jan 2014 (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.
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sole local anesthetic | Experimental | Drug: Sole local anesthetic, Drug: RopivacaineEpidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently |
| Opioid plus local anesthetic | Active comparator | Drug: Sufentanil (Opioid plus local anesthetic), Drug: RopivacaineEpidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nulliparas
- Request epidural analgesia
- Chinese
Key exclusion criteria (4 listed)
- Allergic to opioid or local anesthetics
- Fail to perform epidural puncture and catheterization
- Organ dysfunction
- Contraindications for epidural anesthesia
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 |
|---|---|---|
| Sole local anestheticAlso: Ropivacaine, Naropin0.125% ropivacaine 10-15 ml every 1h during labor delivery | Drug | Sole local anesthetic |
| Sufentanil (Opioid plus local anesthetic)Also: NaropinSufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery | Drug | Opioid plus local anesthetic |
| Ropivacaine | Drug | Opioid plus local anesthetic, Sole local anesthetic |
Primary outcome
Pain scorings
Time frame: up to 3 days
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
12 secondary outcomes
Pruritus
Time frame: From post-randomization to post-delivery day 3
Dizziness
Time frame: From post-randomization to post-delivery day 3
Nausea
Time frame: From post-randomization to post-delivery day 3
Vomiting
Time frame: From post-randomization to post-delivery day 3
Drowsiness
Time frame: From post-randomization to post-delivery day 3
Sedation
Time frame: From post-randomization to post-delivery day 3
Respiratory depression
Time frame: From post-randomization to post-delivery day 3
Psychological effects
Time frame: From post-randomization to post-delivery day 3
Myoclonus
Time frame: From post-randomization to post-delivery day 3
Maternal heart rate
Time frame: From post-randomization to post-delivery day 3
Miosis
Time frame: From post-randomization to post-delivery day 3
Cesarean section
Time frame: The time at the end of the labor delivery
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 4 Feb 2014.
- Derived from this study: PubMed 26512604Wang X, Xu S, Qin X, Li X, Feng SW, Liu Y, Wang W, Guo X, Shen R, Shen X, Wang F. Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia. Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882.
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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 Phase 4 study testing Sole local anesthetic, Sufentanil (Opioid plus local anesthetic) and Ropivacaine in people with Pain, run by Nanjing Medical University 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 3 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 4 Feb 2014. 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.
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?
Pain scorings (time frame: up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036242, which also lists 1 linked publication.
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 4 Feb 2014.