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Difficulty in recruitment
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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB efficacy advantage.
Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained. Pregnant participants will receive a labor epidural upon the patient's request and dosed per protocol to adequate analgesic level.
Patients will be randomized into 1 of 4 groups. Either group I or II in Study Part A and group III or IV in Study Part B in a double-blinded design. Each study part will run in parallel and independently.
Each group will have a varying concentration of bupivicaine infusion; continuous or intermittent bolus administration. In addition each group will have continuous or intermittent bolus administration of sufentanil. These concentrations and forms of administration will be blinded to both the patient and study administrator.
Each epidural infusion concentration and continuous or bolus administration will be determined to be a success or failure based on analgesic scores. The investigators' primary outcome will be the minimal local anesthetic concentration of the final participants in each respective group upon study completion.
DATA SAFETY MONITORING PLAN will follow standard of clinical care. Any adverse events will be reported to the PI and necessary adjustments to the protocol will be immediately instituted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Group 1 | Active Comparator | CEI bupivacaine and CEI sufentanil |
|
| Part A Group 2 | Active Comparator | PIEB bupivacaine and PIEB sufentanil |
|
| Part B Group 3 | Active Comparator | CEI bupivacaine and PIEB sufentanil |
|
| Part B Group 4 | Active Comparator | PIEB bupivacaine and CEI sufentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Continuous or bolus administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion | The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups. | From initial epidural bolus to delivery (up to approximately 16 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose) | The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups. | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Numerical Verbal Pain Scores |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Pruritis | scale from from 0-10 | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Motor Weakness | Straight leg lift, yes/no |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Carvalho, MBBCh, MDCH | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23223119 | Background | George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. | |
| 14570662 | Background | Ginosar Y, Columb MO, Cohen SE, Mirikatani E, Tingle MS, Ratner EF, Angst MS, Riley ET. The site of action of epidural fentanyl infusions in the presence of local anesthetics: a minimum local analgesic concentration infusion study in nulliparous labor. Anesth Analg. 2003 Nov;97(5):1439-1445. doi: 10.1213/01.ANE.0000081792.84877.A2. |
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Patients who met the protocol-specified "reject" criteria were censored (had no subsequent outcome measure data collected and were not considered analyzable for outcome measures) and were considered to have completed the study. Upon reject, catheter management was at discretion of anesthesia care provider.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Group 1 | CEI bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| FG001 | Part A Group 2 | PIEB bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| FG002 | Part B Group 3 | CEI bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| FG003 | Part B Group 4 | PIEB bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Group 1 | CEI bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| BG001 | Part A Group 2 | PIEB bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion | The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Mean | Standard Deviation | % mg/ml | From initial epidural bolus to delivery (up to approximately 16 hours) |
|
From initial epidural bolus to delivery (up to approximately 16 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Group 1 | CEI bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
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This study did not meet its planned enrollment and did not achieve power for the intended analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brendan Carvalho | Stanford University School of Medicine | (650) 861-8607 | bcarvalho@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2015 | Jul 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Sufentanil | Drug | Continuous or bolus administration |
|
|
The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups. |
| Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Patient Satisfaction With Labor Analgesia | 0-100% (0 means least satisfaction and 100 means most satisfaction) | Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours) |
| Labor Outcome (Spontaneous, Assisted, Cesarean) | Labor outcome in patients who have success or failure outcome were compared between groups. | At the time of delivery |
| Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension | Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported. | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Number of Participants With Maternal Nausea/Vomiting | yes/no. | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Protocol Success or Failure | Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -> 0.01% w/v reduction in subsequent participant's local anesthetic. Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation ->0.01% w/v increase in subsequent LA infusion. | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Number and Total Dose of Clinician Rescue Boluses | From initial epidural bolus to approximately 6-12 hours following delivery |
| Total CEI and PIEB Local Anesthetic and Opioid Use | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Requests to Turn Epidural Down or Stop Infusion. | yes/no | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| Duration of Epidural Analgesia | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
| BG002 | Part B Group 3 | CEI bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| BG003 | Part B Group 4 | PIEB bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Part B Group 3 | CEI bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
| OG003 | Part B Group 4 | PIEB bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration |
|
|
| Secondary | Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose) | The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Mean | Standard Deviation | hours | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
|
|
|
| Secondary | Numerical Verbal Pain Scores | The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Mean | Standard Deviation | score on a scale | Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus) |
|
|
|
| Secondary | Patient Satisfaction With Labor Analgesia | 0-100% (0 means least satisfaction and 100 means most satisfaction) | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Mean | Standard Deviation | score on a scale | Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours) |
|
|
|
| Secondary | Labor Outcome (Spontaneous, Assisted, Cesarean) | Labor outcome in patients who have success or failure outcome were compared between groups. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Count of Participants | Participants | At the time of delivery |
|
|
|
| Secondary | Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension | Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Count of Participants | Participants | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
|
|
|
| Secondary | Number of Participants With Maternal Nausea/Vomiting | yes/no. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Count of Participants | Participants | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
|
|
|
| Secondary | Protocol Success or Failure | Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -> 0.01% w/v reduction in subsequent participant's local anesthetic. Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation ->0.01% w/v increase in subsequent LA infusion. | Analyzable data set (did not meet the protocol-specified "reject" criteria). | Posted | Count of Participants | Participants | From initial epidural bolus to delivery (up to 16 hours following initial bolus) |
|
|
|
| Other Pre-specified | Maternal Pruritis | scale from from 0-10 | Not Posted | From initial epidural bolus to delivery (up to 16 hours following initial bolus) | Participants |
| Other Pre-specified | Motor Weakness | Straight leg lift, yes/no | Not Posted | From initial epidural bolus to delivery (up to 16 hours following initial bolus) | Participants |
| Other Pre-specified | Number and Total Dose of Clinician Rescue Boluses | Not Posted | From initial epidural bolus to approximately 6-12 hours following delivery | Participants |
| Other Pre-specified | Total CEI and PIEB Local Anesthetic and Opioid Use | Not Posted | From initial epidural bolus to delivery (up to 16 hours following initial bolus) | Participants |
| Other Pre-specified | Requests to Turn Epidural Down or Stop Infusion. | yes/no | Not Posted | From initial epidural bolus to delivery (up to 16 hours following initial bolus) | Participants |
| Other Pre-specified | Duration of Epidural Analgesia | Not Posted | From initial epidural bolus to delivery (up to 16 hours following initial bolus) | Participants |
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Part A Group 2 | PIEB bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part B Group 3 | CEI bupivacaine and PIEB sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Part B Group 4 | PIEB bupivacaine and CEI sufentanil Bupivacaine: Continuous or bolus administration Sufentanil: Continuous or bolus administration | 0 | 8 | 0 | 8 | 0 | 8 |
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| D000588 |
| Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| C-section |
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| Failure |
|