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Lack of continued funding
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Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space.
Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia.
Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia.
The hypothesis of this study is: patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will have a longer duration of adequate analgesia (time to first manual re-dose request) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower concentration local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low volume bolus | Experimental | 6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) |
|
| High volume bolus | Experimental | 10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low volume bolus | Drug | Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia Provider Administered Bolus | Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| VAS at 10 Centimeters Dilation of Cervix | VAS (visual analogue scale) at 10 centimeters dilation of cervix on a scale of 0 (no pain,good) to 100 (worst pain imaginable,bad) | 24 hours |
| VAS Score After Delivery |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant female
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| Name | Affiliation | Role |
|---|---|---|
| Feyce Peralta, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16492849 | Background | Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a. | |
| 16154735 | Background | Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004. |
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146 subjects consented to participate in the study.
Subjects were recruited within Prentice Women's Hospital labor and delivery unit. Recruitment period start date was 1/21/2020 and the end date for recruitment was 09/01/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Volume Bolus 0.1% Bupivacaine | 6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
| FG001 | High Volume Bolus .0625% Bupivacaine | 10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Volume Bolus 0.1% Bupivacaine | 6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Anesthesia Provider Administered Bolus | Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby. | Posted | Count of Participants | Participants | 72 hours |
|
72 hours after epidural catheter placement.
Intrascapular pain
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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 | Low Volume Bolus 0.1% Bupivacaine | 6.25 mL administration at 250 ml per hour of a greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) Low volume bolus: Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intrascapular Pain | Nervous system disorders | Systematic Assessment | Intrascapular pain as relating to the administration of anesthetic agents via epidural catheter. |
A larger study would need to evaluate the secondary outcomes as the current study was underpowered to evaluate the analgesic secondary outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.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 | Dec 14, 2022 | Apr 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Two group randomized controlled trial
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The participant and outcomes assessor will be blinded to the assigned randomization.
| High volume bolus | Drug | Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
|
VAS score (Visual Analogue Scale) on a score of 0 (no pain,good) to 100 (worst pain imaginable,bad) immediately after delivery of baby
| 24 hours |
| Intrascapular Pain | Number of participants who experienced intrascapular pain (pain in your shoulder blade) during the study period. | 72 hours |
| Provider Administered Bolus | Number of participants requiring anesthesia provider administration of additional bolus doses of pain medication. | 72 hours |
| Number of Participants Who Required Additional Provider Redoses | Additional number of participants who required additional anesthesia care provider redoses of pain medication. | 72 hours |
| Time to First Anesthesiology Provider Bolus | Time elapsed in minutes from epidural set up to time to request supplemental analgesia provided by the anesthesiology care provider. | 72 hours |
| VAS Score Prior to First Provider Bolus Dose | Patient reported visual analogue scale score (0 no pain,good-100 worst pain imaginable, bad) prior to the first anesthesiology care provider bolus dose of anesthetic (pain medication). | 72 hours |
| VAS Score 30 Minutes After Anesthetic Care Provider Dose | Patient reported visual analogue scale score (0 no pain, good -100 worst pain imaginable, bad) 30 minutes after the first anesthesiology care provider bolus dose of anesthetic was administered to the participant for pain relief. | 72 hours |
| Bupivacaine Consumption Per Hour | Average consumption of bupivacaine in milligrams per hour. | 72 hours |
| Maximum Oxytocin Dose | Maximum oxytocin dose administered intravenously in international units. | 72 hours |
| Time of Intrathecal Administration to Delivery | Elapsed time in minutes from the intrathecal administration of anesthetic by anesthesiology provider to time of delivery of baby. | 72 hours |
| Number of Participants Categorized by Mode of Delivery | Mode of delivery identified as: normal vaginal delivery, instrumental vaginal delivery, cesarean delivery or emergency cesarean delivery | 72 hours |
| PCA Boluses | Number of Patient-Controlled Epidural Analgesia (PCEA) boluses of pain medication requested and number of PCEA medication boluses administered. | 72 hours |
| PCA Boluses Ratio | The ratio of the number of Patient-Controlled Epidural Analgesia (PCEA) pain medication boluses requested and number of PCEA pain medication boluses administered by the PCEA pump. | 72 hours |
| 15197122 | Background | Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402. |
| 10439786 | Background | Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available. |
| 11915061 | Background | Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748. |
| 11454372 | Background | Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X. |
| No cerebral spinal fluid obtained during epidural procedure a straight catheter was used |
|
| Fentanyl and or clonidine administered via epidural catheter |
|
| First redose of anesthetic by anesthesiologist administered under 90 minutes after catheter placed |
|
| Greater than 3 redoses of anesthetic by the anesthesiologist using the epidural catheter |
|
| Physician Decision |
|
| High Volume Bolus .0625% Bupivacaine |
10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Mean | Full Range | Weeks |
|
| BMI kg/m^2 | Mean | Full Range | kg/m^2 |
|
| Number of times pregnant | Count of Participants | Participants |
|
| Labor type | Count of Participants | Participants |
|
| Fetal position | The position of the fetus within the uterus of the mother | Count of Participants | Participants |
|
| Cervical dilation at labor analgesia request (cm) | Cervical dilation at labor analgesia request (cm).Cervical dilation is measured in centimeters (cm). | Mean | Inter-Quartile Range | Centimeters |
|
| VAS scores (0 to 100) at labor analgesia request | VAS (verbal analogue scale) response on a 0 (no pain, good) to 100 (worst pain imaginable,bad) scale. | Mean | Full Range | units on a scale (0 low (good)-100 high) |
|
|
|
| Secondary | VAS at 10 Centimeters Dilation of Cervix | VAS (visual analogue scale) at 10 centimeters dilation of cervix on a scale of 0 (no pain,good) to 100 (worst pain imaginable,bad) | Posted | Median | Inter-Quartile Range | score on a scale 0 good 100 worst | 24 hours |
|
|
|
| Secondary | VAS Score After Delivery | VAS score (Visual Analogue Scale) on a score of 0 (no pain,good) to 100 (worst pain imaginable,bad) immediately after delivery of baby | Posted | Median | Inter-Quartile Range | score on a scale 0 good-100 bad | 24 hours |
|
|
|
| Secondary | Intrascapular Pain | Number of participants who experienced intrascapular pain (pain in your shoulder blade) during the study period. | Posted | Number | Participants | 72 hours |
|
|
|
| Secondary | Provider Administered Bolus | Number of participants requiring anesthesia provider administration of additional bolus doses of pain medication. | Posted | Number | participants | 72 hours |
|
|
|
| Secondary | Number of Participants Who Required Additional Provider Redoses | Additional number of participants who required additional anesthesia care provider redoses of pain medication. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | Time to First Anesthesiology Provider Bolus | Time elapsed in minutes from epidural set up to time to request supplemental analgesia provided by the anesthesiology care provider. | Posted | Median | Inter-Quartile Range | Minutes | 72 hours |
|
|
|
| Secondary | VAS Score Prior to First Provider Bolus Dose | Patient reported visual analogue scale score (0 no pain,good-100 worst pain imaginable, bad) prior to the first anesthesiology care provider bolus dose of anesthetic (pain medication). | Posted | Median | Inter-Quartile Range | score on a scale 0 good-100 bad | 72 hours |
|
|
|
| Secondary | VAS Score 30 Minutes After Anesthetic Care Provider Dose | Patient reported visual analogue scale score (0 no pain, good -100 worst pain imaginable, bad) 30 minutes after the first anesthesiology care provider bolus dose of anesthetic was administered to the participant for pain relief. | Posted | Median | Inter-Quartile Range | score on a scale 0 good-100 bad | 72 hours |
|
|
|
| Secondary | Bupivacaine Consumption Per Hour | Average consumption of bupivacaine in milligrams per hour. | Posted | Mean | Standard Deviation | milligrams/hour | 72 hours |
|
|
|
| Secondary | Maximum Oxytocin Dose | Maximum oxytocin dose administered intravenously in international units. | Posted | Median | Inter-Quartile Range | International Units | 72 hours |
|
|
|
| Secondary | Time of Intrathecal Administration to Delivery | Elapsed time in minutes from the intrathecal administration of anesthetic by anesthesiology provider to time of delivery of baby. | Posted | Median | Inter-Quartile Range | Minutes | 72 hours |
|
|
|
| Secondary | Number of Participants Categorized by Mode of Delivery | Mode of delivery identified as: normal vaginal delivery, instrumental vaginal delivery, cesarean delivery or emergency cesarean delivery | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | PCA Boluses | Number of Patient-Controlled Epidural Analgesia (PCEA) boluses of pain medication requested and number of PCEA medication boluses administered. | Posted | Median | Inter-Quartile Range | Boluses | 72 hours |
|
|
|
| Secondary | PCA Boluses Ratio | The ratio of the number of Patient-Controlled Epidural Analgesia (PCEA) pain medication boluses requested and number of PCEA pain medication boluses administered by the PCEA pump. | Posted | Median | Inter-Quartile Range | Ratio of requested to delivered boluses | 72 hours |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | High Volume Bolus .0625% Bupivacaine | 10 mL administration of a lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). High volume bolus: Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump. | 0 | 62 | 0 | 62 | 3 | 62 |
|
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| 2 Redoses |
|
| 3 Redoses |
|
| 4 Redoses |
|
| Cesarean Delivery |
|