Trial · NCT02973048
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
NCT02973048, Phase 3, Completed, Centre Hospitalier Universitaire Saint Pierre; results first posted 2020-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia. Trials, record NCT02973048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02973048
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
- NCT number
- NCT02973048
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Conditions
- Pregnant Women, Pain, Hypotension
- Interventions
- Hyperbaric bupivacaine, Hyperbaric prilocaine
- First posted
- 2016-11-25
- Last updated
- 2020-07-02
- Results first posted
- 2020-07-02
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Regression of Motor Block | until complete regression of motor block (up to 4 hours) | Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block |
| Secondary | Time to Successful Anesthesia (Successful Sensory Block) | From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes) | Time between spinal injection and reached bilateral T4 sensory level. |
| Secondary | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | until complete release of sensory block (T12-S1) (average 4 hours) | Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels. To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained. The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia. |
| Secondary | Time to Resolution of Sensory Block | until complete release of sensory block (T12-S1) (average 4 hours) | Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1). |
| Secondary | Time to Motor Block Onset | From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour) | Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia |
| Secondary | Number of Patients With Hypotension and Use of Vasopressors | up to 2 hours after surgery | Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia) |
| Secondary | Number of Participants With Urinary Retention | up to 4 hours after surgery | All parturients will be questioned and examined for urinary retention (yes or no) |
| Secondary | Time to First Walk | up to 24h after surgery | Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time. |
| Secondary | Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) | up to 24 hours after surgery | All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied) |
| Secondary | Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) | up to 72 hours after surgery | Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent) |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Regression of Motor Block | until complete regression of motor block (up to 4 hours) | minutes | MEDIAN | |
| SECONDARY | Time to Successful Anesthesia (Successful Sensory Block) | From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes) | minutes | MEAN | |
| SECONDARY | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | until complete release of sensory block (T12-S1) (average 4 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Resolution of Sensory Block | until complete release of sensory block (T12-S1) (average 4 hours) | minutes | MEAN | |
| SECONDARY | Time to Motor Block Onset | From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour) | minutes | MEDIAN | |
| SECONDARY | Number of Patients With Hypotension and Use of Vasopressors | up to 2 hours after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Urinary Retention | up to 4 hours after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Walk | up to 24h after surgery | Minutes | MEDIAN | |
| SECONDARY | Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) | up to 24 hours after surgery | score on a scale | MEDIAN | |
| SECONDARY | Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) | up to 72 hours after surgery | score on a scale | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Regression of Motor Block | Hyperbaric Bupivacaine | 180 | Inter-Quartile Range 142.5 to 239.5 | minutes | |
| Time to Regression of Motor Block | Hyperbaric Prilocaine | 130 | Inter-Quartile Range 120 to 166 | minutes | |
| Time to Successful Anesthesia (Successful Sensory Block) | Hyperbaric Bupivacaine | 9.63 | Standard Deviation 3.48 | minutes | |
| Time to Successful Anesthesia (Successful Sensory Block) | Hyperbaric Prilocaine | 11.18 | Standard Deviation 2.7 | minutes | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Bupivacaine | Sensory level dermatome C5 | 0 | Participants | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Prilocaine | Sensory level dermatome C5 | 1 | Participants | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Bupivacaine | Sensory level dermatome C6 | 3 | Participants | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Prilocaine | Sensory level dermatome C6 | 1 | Participants | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Bupivacaine | Sensory level dermatome C7 | 0 | Participants | |
| Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Hyperbaric Prilocaine | Sensory level dermatome C7 | 0 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hyperbaric Bupivacaine | 20 | |
| Overall Study | STARTED | Hyperbaric Prilocaine | 20 | |
| Overall Study | COMPLETED | Hyperbaric Bupivacaine | 19 | |
| Overall Study | COMPLETED | Hyperbaric Prilocaine | 17 | |
| Overall Study | NOT COMPLETED | Hyperbaric Bupivacaine | 1 | |
| Overall Study | NOT COMPLETED | Hyperbaric Prilocaine | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Transient neurologic symptoms | Nervous system disorders | Hyperbaric Bupivacaine | 1 | 19 | |
| other | Transient neurologic symptoms | Nervous system disorders | Hyperbaric Prilocaine | 1 | 17 | |
| other | Nausea | Gastrointestinal disorders | Hyperbaric Bupivacaine | 8 | 19 | |
| other | Nausea | Gastrointestinal disorders | Hyperbaric Prilocaine | 7 | 17 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hyperbaric Bupivacaine | 0 | 19 |
| Total, all-cause mortality | Hyperbaric Prilocaine | 0 | 17 |
| Total, other adverse events | Hyperbaric Bupivacaine | 8 | 19 |
| Total, other adverse events | Hyperbaric Prilocaine | 8 | 17 |
| Total, serious adverse events | Hyperbaric Bupivacaine | 0 | 19 |
| Total, serious adverse events | Hyperbaric Prilocaine | 0 | 17 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Hyperbaric Bupivacaine vs Hyperbaric Prilocaine: Number of Participants With Transient Neurologic Symptoms (TNS) | Trial comparisons |
| Hyperbaric Bupivacaine vs Hyperbaric Prilocaine: Number of Participants With Urinary Retention | Trial comparisons |
| Hyperbaric Bupivacaine vs Hyperbaric Prilocaine: deaths from any cause | Trial comparisons |
| Hyperbaric Bupivacaine vs Hyperbaric Prilocaine: 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/NCT02973048
GET https://conductscience.org/api/trials/v1/NCT02973048/registered?page=2