Labor PainPhase 4PIEBNCT06266767
Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia
A Phase 4 study testing Levobupivacaine and Fentanyl in people with Labor Pain and Obstetric Pain, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain, Obstetric Pain, Analgesia
- What is being tested?
- Levobupivacaine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteQatar
- Study dates
- 21 Feb 2024to 5 Oct 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 yrs
- In active labour
- ASA 2 patients (pregnant patients are considered to be ASA 2)
- Singleton pregnancy
- > 37 weeks gestation
- Booking BMI 18 to 35
Who cannot join
- BMI < 18
- BMI > 35
- Systemic opioids within the previous 6 hours
- Presence of a fetal anomaly
- Pre-eclampsia
- Bleeding disorders (including coagulation disorders)
Show all 12Show fewer
- Recent spinal surgery
- Spinal injury
- Elevated intracranial pressure (ICP)
- Neuraxial disorders of any description
- Signs of local or systemic infection
- Patient refusal for neuraxial analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia; Finding the Optimum Combination
Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score.
Read the detailed description
Many women experience severe pain during labour. There are many forms of pain relief methods available to women in developed countries. Labour epidural analgesia remains the most effective form of pain relief. It is also the least depressive to the central nervous system of the mother and the baby. After initiating epidural analgesia, there are many regimens that can be employed to maintain analgesia for the duration of labour.
Traditionally, epidural analgesia (using low dose mixtures of local anaesthetic and opioid) has been administered by nurse or midwife-controlled manual boluses or as continuous infusion via a dedicated epidural pump (once the epidural catheter has been placed by an anaesthetist). Although these regimens provide an effective form of labour analgesia, patient satisfaction is not always achieved because of the associated lower limb motor block (leg weakness) and the increased risk of requiring instrumental delivery such as a forceps delivery. Due to recent advances in medical technology, new epidural pumps, which allow patient controlled epidural analgesia (PCEA) boluses and programmed intermittent epidural (PIEB) boluses, are now available.
Bolus injection through an epidural catheter may result in better distribution of anaesthetic solution in the epidural space when compared with continuous infusion of the same low dose local anaesthetic / opioid mixture. Capogna et al carried out a randomized double-blind study to compare the effects of a programmed intermittent epidural bolus (PIEB) regimen with a continuous epidural infusion (CEI). Motor block was reported in 37% in the CEI group and in only 2.7% in the PIEB group (P < 0.001). The incidence of instrumental delivery was 20% for the CEI group and 7% for the PIEB group (P = 0.03). The total local anaesthetic consumption, number of patients requiring additional PCEA boluses, and mean number of PCEA boluses per patient were also found to be lower in the PIEB group (P < 0.001). There were no differences in pain scores and duration of labour analgesia. (Capogna et al, 2011) Another randomized controlled study published by Wong et al compared total local anaesthetic (bupivacaine was used in this study) consumption, need for supplemental epidural analgesia, quality of analgesia, and patient satisfaction in women who received programmed intermittent epidural boluses (PIEB) compared with continuous epidural infusion (CEI) for maintenance of labour epidural analgesia. The median total bupivacaine dose per hour of analgesia was significantly less in the PIEB (n = 63) (10.5 mg/h; 95% confidence interval, 9.5-11.8 mg/h) when compared with the CEI group (n = 63) (12.3 mg/h; 95% confidence interval, 10.5-14.0 mg/h) (P < 0.01). Patient satisfaction scores were also higher in the PIEB group. The authors concluded that PIEB combined with patient controlled epidural analgesia (PCEA) provided similar analgesia, but with a smaller bupivacaine dose and better patient satisfaction compared with CEI with PCEA for maintenance of epidural labour analgesia. (Wong et al, 2006) Wong et al carried out another study to evaluate bupivacaine consumption and other analgesic outcomes when the programmed intermittent bolus time interval and volume were manipulated during the maintenance of epidural labour analgesia. They found that extending the programmed intermittent bolus interval and volume from 15 minutes to 60 minutes, and 2.5 mL to 10 mL, respectively, decreased bupivacaine consumption without decreasing patient comfort or satisfaction. (Wong et al, 2011) In our study, we aim to compare the effects of different combinations of PIEB bolus volume and PIEB time interval on the number of PCEA demands / clinician boluses, pain score, local anaesthetic consumption and patient satisfaction in order to find the optimal PIEB volume and PIEB time interval for labour pain relief when used together with a fixed (pre-determined) PCEA regimen.
- Conditions
- Labor Pain, Obstetric Pain, Analgesia
- Being tested
- Levobupivacaine and Fentanyl
- Keywords
- Obstetrics, Analgesia, Epidural, Patient-Controlled, Opioid
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine and FentanylDrug
Programmed Intermittent Epidural Bolus
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | PIEB bolus vol (ml) : 8 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 2 | Experimental | PIEB bolus vol (ml) : 8 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 3 | Experimental | PIEB bolus vol (ml) : 10 PIEB time interval (min) : 30 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 4 | Experimental | PIEB bolus vol (ml) : 10 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 5 | Experimental | PIEB bolus vol (ml) : 10 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 6 | Experimental | PIEB bolus vol (ml) : 10 PIEB time interval (min) : 75 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 7 | Experimental | PIEB bolus vol (ml) : 12 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
| Group 8 | Experimental | PIEB bolus vol (ml) : 12 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 Receives: Drug: Levobupivacaine and Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score
The (composite) primary outcome will identify the 2 best performing groups
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Secondary outcomes (7)
Pain score
Numeric Rating Scale (NRS). Patient self-reported pain scale. 0 (No Pain) to 10 (Worst possible pain)
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Total local anesthetic consumption
Initial Epidural Bolus + Total volume PIEB + Total volume PCEA + Clinician bolus volume
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Need for supplementary epidural analgesia
Total volume PCEA + Total volume clinician Bolus
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Bromage score (lower limb weakness score)
Bromage Score -1: Free movement of legs and feet, 2: Just able to flex knees, able to move feet, 3: Unable to flex knees, able to move feet, 4 :Unable to move legs or feet
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Type of delivery
Normal vaginal delivery, cesarean delivery, forceps and vacuum delivery
Measured: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Sensory block
Assessed with cold spray (ethyl chloride)
Measured: From the siting of the epidural block for 3 hours
Fetal Outcome
Umbilical cord blood gases + Apgar scores
Measured: At the time of birth and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start21 Feb 2024
- Primary completion5 Oct 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups. There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshan Fernando, MD, Principal investigator, Hamad Medical Corporation, QatarFatima Khatoon, DESAIC, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266767
- Sponsor's protocol ID
- MRC-01-18-157
- Acronym
- PIEB
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia; Finding the Optimum Combination
- ClinicalTrials.gov ID
- NCT06266767
- Acronym / sponsor ID
- PIEB / MRC-01-18-157
- Conditions
- Labor Pain, Obstetric Pain, Analgesia
- Keywords
- Obstetrics, Analgesia, Epidural, Patient-Controlled, Opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 20 Feb 2024 (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.
Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score.
Detailed description
Many women experience severe pain during labour. There are many forms of pain relief methods available to women in developed countries. Labour epidural analgesia remains the most effective form of pain relief. It is also the least depressive to the central nervous system of the mother and the baby. After initiating epidural analgesia, there are many regimens that can be employed to maintain analgesia for the duration of labour.
Traditionally, epidural analgesia (using low dose mixtures of local anaesthetic and opioid) has been administered by nurse or midwife-controlled manual boluses or as continuous infusion via a dedicated epidural pump (once the epidural catheter has been placed by an anaesthetist). Although these regimens provide an effective form of labour analgesia, patient satisfaction is not always achieved because of the associated lower limb motor block (leg weakness) and the increased risk of requiring instrumental delivery such as a forceps delivery. Due to recent advances in medical technology, new epidural pumps, which allow patient controlled epidural analgesia (PCEA) boluses and programmed intermittent epidural (PIEB) boluses, are now available.
Bolus injection through an epidural catheter may result in better distribution of anaesthetic solution in the epidural space when compared with continuous infusion of the same low dose local anaesthetic / opioid mixture. Capogna et al carried out a randomized double-blind study to compare the effects of a programmed intermittent epidural bolus (PIEB) regimen with a continuous epidural infusion (CEI). Motor block was reported in 37% in the CEI group and in only 2.7% in the PIEB group (P < 0.001). The incidence of instrumental delivery was 20% for the CEI group and 7% for the PIEB group (P = 0.03). The total local anaesthetic consumption, number of patients requiring additional PCEA boluses, and mean number of PCEA boluses per patient were also found to be lower in the PIEB group (P < 0.001). There were no differences in pain scores and duration of labour analgesia. (Capogna et al, 2011) Another randomized controlled study published by Wong et al compared total local anaesthetic (bupivacaine was used in this study) consumption, need for supplemental epidural analgesia, quality of analgesia, and patient satisfaction in women who received programmed intermittent epidural boluses (PIEB) compared with continuous epidural infusion (CEI) for maintenance of labour epidural analgesia. The median total bupivacaine dose per hour of analgesia was significantly less in the PIEB (n = 63) (10.5 mg/h; 95% confidence interval, 9.5-11.8 mg/h) when compared with the CEI group (n = 63) (12.3 mg/h; 95% confidence interval, 10.5-14.0 mg/h) (P < 0.01). Patient satisfaction scores were also higher in the PIEB group. The authors concluded that PIEB combined with patient controlled epidural analgesia (PCEA) provided similar analgesia, but with a smaller bupivacaine dose and better patient satisfaction compared with CEI with PCEA for maintenance of epidural labour analgesia. (Wong et al, 2006) Wong et al carried out another study to evaluate bupivacaine consumption and other analgesic outcomes when the programmed intermittent bolus time interval and volume were manipulated during the maintenance of epidural labour analgesia. They found that extending the programmed intermittent bolus interval and volume from 15 minutes to 60 minutes, and 2.5 mL to 10 mL, respectively, decreased bupivacaine consumption without decreasing patient comfort or satisfaction. (Wong et al, 2011) In our study, we aim to compare the effects of different combinations of PIEB bolus volume and PIEB time interval on the number of PCEA demands / clinician boluses, pain score, local anaesthetic consumption and patient satisfaction in order to find the optimal PIEB volume and PIEB time interval for labour pain relief when used together with a fixed (pre-determined) PCEA regimen.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
- Model description
- We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups. There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 8 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 2 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 8 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 3 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 10 PIEB time interval (min) : 30 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 4 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 10 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 5 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 10 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 6 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 10 PIEB time interval (min) : 75 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 7 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 12 PIEB time interval (min) : 60 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
| Group 8 | Experimental | Drug: Levobupivacaine and FentanylPIEB bolus vol (ml) : 12 PIEB time interval (min) : 45 PCEA bolus vol (ml) : 5 PCEA lockout time interval (min) : 20 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 50 yrs
- In active labour
- ASA 2 patients (pregnant patients are considered to be ASA 2)
- Singleton pregnancy
- > 37 weeks gestation
Key exclusion criteria (12 listed)
- BMI < 18
- BMI > 35
- Systemic opioids within the previous 6 hours
- Presence of a fetal anomaly
- Pre-eclampsia
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 |
|---|---|---|
| Levobupivacaine and FentanylProgrammed Intermittent Epidural Bolus | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8 |
Primary outcome
The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
The (composite) primary outcome will identify the 2 best performing groups
7 secondary outcomes
Pain score
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Total local anesthetic consumption
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Need for supplementary epidural analgesia
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Bromage score (lower limb weakness score)
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Type of delivery
Time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)
Sensory block
Time frame: From the siting of the epidural block for 3 hours
Fetal Outcome
Time frame: At the time of birth and 5 minutes after 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 1 Nov 2024.
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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.
Roshan Fernando, MD principal investigator
Hamad Medical Corporation, Qatar
Fatima Khatoon, DESAIC principal investigator
Hamad Medical Corporation
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 Levobupivacaine and Fentanyl in people with Labor Pain and Obstetric Pain, run by Hamad Medical Corporation at 1 site in Qatar.
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 12 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 Nov 2024. 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 Qatar. 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?
The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score (time frame: From the siting of the epidural block to the delivery of the fetus (maximum 24 hrs)). 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 Nov 2024.