Trial · NCT01621230
Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor
NCT01621230, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2020-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor. Trials, record NCT01621230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01621230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor
- NCT number
- NCT01621230
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 481 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Pregnancy
- Interventions
- Epidural Bupivacaine plus fentanyl, Epidural fentanyl
- First posted
- 2012-06-18
- Last updated
- 2020-08-24
- Results first posted
- 2020-08-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Duration of the Second Stage of Labor | Duration of second stage of labor approximately 30 minutes to 150 minutes | The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone. |
| Secondary | Local Anesthetic Motor Blockade Indices During Stage II of Labor | Duration of second stage of labor approximately 30 minutes to 150 minutes | Motor blockade will be estimated using Bromage and Breen scores (measured on a 6-point standardized scale, 1= Unable to more feet, 6= Able to perform partial knee bend) that estimate motor blockade. This scoring system is based upon the laboring womans' ability to move her lower extremities. |
| Secondary | Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | At the time of Delivery | |
| Secondary | Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min | At the time of Delivery, up to 3 hours | Number of participants whose newborns received an APGAR score of \<=3 at 1 min. A lower APGAR score represents poor health or a worsening in the Outcome, |
| Secondary | Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min | At the time of Delivery, up to 3 hours | Number of participants whose newborns received an APGAR score of \<=3 at 5 minutes. A lower APGAR score represents poor health or a worsening in the Outcome |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Duration of the Second Stage of Labor | Duration of second stage of labor approximately 30 minutes to 150 minutes | minutes | MEDIAN | |
| SECONDARY | Local Anesthetic Motor Blockade Indices During Stage II of Labor | Duration of second stage of labor approximately 30 minutes to 150 minutes | PI for this study is deceased and the relevant data have been destroyed. The underlying data are not available for accurately reporting the information in this Outcome Measure | ||
| SECONDARY | Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | At the time of Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min | At the time of Delivery, up to 3 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min | At the time of Delivery, up to 3 hours | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Duration of the Second Stage of Labor | Group I (Bupivacaine) | 75 | Full Range 41 to 128 | minutes | |
| The Duration of the Second Stage of Labor | Group II (No Bupivacaine) | 73 | Full Range 42 to 120 | minutes | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Fentanyl | Spontaneous | 126 | Participants | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | Spontaneous | 112 | Participants | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Fentanyl | Forceps-assisted | 12 | Participants | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | Forceps-assisted | 19 | Participants | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Fentanyl | Cesarean | 18 | Participants | |
| Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor | Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | Cesarean | 23 | Participants | |
| Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min | Epidural Fentanyl | 14 | Participants | ||
| Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min | Epidural Bupivacaine Plus Fentanyl (Bupivacaine) | 11 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bupivacaine Plus Fentanyl | 154 | |
| Overall Study | STARTED | Fentanyl Only | 156 | |
| Overall Study | COMPLETED | Bupivacaine Plus Fentanyl | 154 | |
| Overall Study | COMPLETED | Fentanyl Only | 156 | |
| Overall Study | NOT COMPLETED | Bupivacaine Plus Fentanyl | 0 | |
| Overall Study | NOT COMPLETED | Fentanyl Only | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bupivacaine Plus Fentanyl | 0 | 154 |
| Total, all-cause mortality | Fentanyl Alone | 0 | 156 |
| Total, other adverse events | Bupivacaine Plus Fentanyl | 0 | 154 |
| Total, other adverse events | Fentanyl Alone | 0 | 156 |
| Total, serious adverse events | Bupivacaine Plus Fentanyl | 0 | 154 |
| Total, serious adverse events | Fentanyl Alone | 0 | 156 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25254902 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Epidural Fentanyl vs Epidural Bupivacaine Plus Fentanyl (Bupivacaine): Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min | Trial comparisons |
| Bupivacaine Plus Fentanyl vs Fentanyl Alone: deaths from any cause | Trial comparisons |
| Epidural Fentanyl vs Epidural Bupivacaine Plus Fentanyl (Bupivacaine): Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min | Trial comparisons |
| Bupivacaine Plus Fentanyl vs Fentanyl Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01621230
GET https://conductscience.org/api/trials/v1/NCT01621230/registered