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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Qatar1 site
  • Hamad Medical Corporation (HMC)

    Doha, Baladiyat ad Dawhah, 3050

Other trials in Qatar

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.

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 groups in NCT06266767
Study groupRoleWhat they receive
Group 1ExperimentalPIEB 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 2ExperimentalPIEB 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 3ExperimentalPIEB 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 4ExperimentalPIEB 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 5ExperimentalPIEB 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 6ExperimentalPIEB 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 7ExperimentalPIEB 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 8ExperimentalPIEB 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Sensory block

    Assessed with cold spray (ethyl chloride)

    Measured: From the siting of the epidural block for 3 hours

  7. 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.

  1. First posted20 Feb 2024
  2. Study start21 Feb 2024
  3. Primary completion5 Oct 2024
  4. Study completion5 Oct 2024

Resources

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)
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

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.

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PIEB Clinical Trial NCT06266767 | AzTrials