ClinicalTrials.gg
Status unknownNCT03497364CSEAFCSWPPAVUpdated Nov 18, 2020

Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors

An interventional study of bupivacaine and ropivacaine in Cesarean Section and Anesthesia, Spinal, sponsored by Shenzhen People's Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Shenzhen People's Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
930
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause enough anesthesia and obviously decrease the incidence of hypotension without prophylactical prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia was performed for pregnant women after written informed consents. The dose of bupivacaine or ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of uterine artery was monitored The sensory and motor block were evaluated. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological behavior of infant were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.

Read the detailed description
  1. General: This was a single-centre randomized controlled trial performed at ShenZhen People's Hospital of Jinan University. Study protocol was approval was by the Ethics Committee of ShenZhen People's Hospital of Jinan University, ShenZhen, China (Permit No. SZY-00251, Chairperson Prof. Xiaofang Yu) on 8 February 2017. Pregnant women who were scheduled for cesarean section were recruited. Written informed consents were obtained from all patients. Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications were excluded from the study.
  2. Sample Size Calculation: SBP \< 90 mmHg or 70% of the baseline value is defined as hypotension; in the study by Langesaeter et al in Anesthesiology magazine, the incidence of hypotension was 20% with prophylactic phenylephrine, and we considered a ≤ 8% difference in the incidence of hypotension to be of clinical significance. Assuming a type I error protection of 0.05 and a power of 0.80, the sample size for a non-inferiority test (margin Δ=0.08) was estimated using the normal approximation to the binomial distribution. Therefore, each group requires 310 subjects.
  3. Anesthesia: Women were randomly divided into three groups, Bupivacaine group, Ropivacaine group and Control group. After entering the operation room, patients were placed supine with left lateral tilt and blood pressure was measured three times at 1-min intervals. The arithmetic average of the three measured values was regarded as the basal pressure of pregnant women. Next, electrocardiogram and pulse oximetry were also monitored. Supplementary oxygen was given through a facemask. Venipuncture was performed in the forearm vein. In Bupivacaine and Ropivacaine group, 500 ml Ringer's lactate was slow given for subjects before anesthesia without prehydration. In Control group, 1000 ml hydroxyethylstarch (6%) was first infused for subjects in the ward, after that 500 ml Ringer's lactate was slow given for subjects before anesthesia.

    Then, with the subjects in left lateral position, combined spinal-epidural anesthesia was performed as follows: skin was infiltrated by lidocaine at the L3-4 or L4-5 interspace; epidural puncture needle was slowly perpendicularly advanced until the tip passed through the ligamentum flavum and reached to epidural space, which was verified with the loss-of-resistance; then intrathecal injection was carried out by spinal needle of 25G, and the epidural catheter was inserted 4-6 cm. Subjects were then immediately recovered in supine with left lateral tilt. In Bupivacaine group, 0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection. The dose of bupivacaine depended on height of subjects (1.7 ml for 173\~174cm, 1.65 ml for 170\~172cm, 1.6 ml for 168\~169cm, 1.55 ml for 165\~167cm, 1.5 ml for 163\~164cm, 1.45 ml for 160\~162cm, 1.4 ml for 158\~159cm, 1.35 ml for 155\~157cm, 1.3 ml for 153\~154cm, 1.25 ml for 150\~152cm, 1.2 ml for 148\~149cm),1.15 ml for 145\~147cm). In Ropivacaine group, 0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection. The dose of ropivacaine depended on height of subjects (2.3 ml for 173\~174cm, 2.2 ml for 170\~172cm, 2.1ml for 168\~169cm, 2.0 ml for 165\~167cm, 1.9 ml for 163\~164cm, 1.8 ml for 160\~162cm, 1.7 ml for 158\~159cm, 1.6 ml for 155\~157cm, 1.5 ml for 153\~154cm, 1.4 ml for 150\~152cm, 1.3 ml for 148\~149cm, 1.2 ml for 145\~147cm). In Control group, 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects. Immediately after intrathecal injection, in control group, phenylephrine was introduced by continuous infusion pumps programmed for an infusion rate of 0.25 ug.kg-1.min-1 to maintain systolic blood pressure at ≥ 90 mmHg or 70% -100 % of baseline value. In Bupivacaine and Ropivacaine group, no prophylactic phenylephrine was introduced For all subjects, when systolic blood pressure was less than 90 mmHg or 70% of baseline value. 100 ug phenylephrine was given and repeated every 1 min until the systolic blood pressure returned to normal. When heart rate was less than 60 beat/min. 0.5-1mg atropine was given to maintain normal heart rate. Nausea and vomiting were treated with metoclopramide 10 mg i.v. Sensory block level after intrathecal injection was assessed with a 20G hypodermic needle (no sensation to pinprick). When the maximum sensory block height was lower than T8, epidural injection of 2% lidocaine (3ml/5min, total volume was less than 15 ml) was given or anesthetic technique was changed into general anesthesia.

  4. Data acquisition: After intrathecal injection, the blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded every 1 min until fetal delivery and then were recorded every 3 min until the end of surgery. The blood flow volume of uterine artery was monitored by ultrasound.

    The level of sensory block, defined as the loss of pin-prick sensation (20G hypodermic needle) at midclavicular level, was measured every 1 min until it reached the T8 dermatome level and then every 10 min during surgery. The following variables were recorded: time to initial onset of analgesia, time for sensory block to reach the T8 dermatome level, time for sensory block to reach maximum dermatome level, time to two-segment regression of analgesic level, and regression of analgesic level to the S2 dermatome. Anesthesia was considered adequate for surgery if pain sensation was lost at the T8 level.

    Motor block was assessed every 1 min using the Bromage scale (0 = no motor block, 3 = complete motor block of lower limbs) until complete motor block and then every 30 min until the return of normal motor function. The times to complete motor block and complete recovery were recorded. The motor block score when the sensory block level reached T8 was also recorded.

    The time from anesthesia initiation to delivery, time from skin incision to delivery and time from uterus incision to delivery were recorded. The total dose of phenylephrine and total volume of fluid before delivery were recorded. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores at 1 and 5 min were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted.

    Neurologic assessment (muscle force, muscle tone, sucking reflex, rooting reflex, moro reflex and grasp reflex) of the infant was carried out at 2h,4h,8h, 1d,2d,3d,4d and 7d after delivery. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.

  5. Statistical Analysis: Statistical analysis was performed using SPSS 13.0 software package. All metering data were recorded as mean ± standard deviation and Independent-Samples T test or One-way ANOVA was used to compare the metering data. Chi-square test was used to compare the enumeration data. p\<0.05 indicates that the differences have statistical significance.
02

Conditions studied

  • Cesarean Section
  • Anesthesia, Spinal

Browse trials for

Keywords

  • Cesarean Section
  • Hypotension
  • Combined spinal-epidural anesthesia
03

In context

Hypotension

885 studies on the registry are indexed under Hypotension; 195 are open to participants now.

This study's planned enrollment of 930 is above the median of 87 across 590 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Shenzhen People's Hospital is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women who were scheduled for cesarean section.

Exclusion criteria

Exclusion Criteria:

  • Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
930 participants (estimated)

Study arms

  • Experimental
    Bupivacaine group

    Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. The dose of bupivacaine depended on height of subjects.

    Drug: bupivacaine

  • Experimental
    Ropivacaine group

    Pregnant women received combined spinal-epidural anesthesia by injecting ropivacaine. The dose of ropivacaine depended on height of subjects).

    Drug: ropivacaine

  • No intervention
    Control group

    Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects.

Interventions

  • 0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection according to the height of subjects (1.7 ml for 173\~174cm, 1.65 ml for 170\~172cm, 1.6 ml for 168\~169cm, 1.55 ml for 165\~167cm, 1.5 ml for 163\~164cm, 1.45 ml for 160\~162cm, 1.4 ml for 158\~159cm, 1.35 ml for 155\~157cm, 1.3 ml for 153\~154cm, 1.25 ml for 150\~152cm, 1.2 ml for 148\~149cm),1.15 ml for 145\~147cm).

  • 0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection according to the height of subjects (2.300 ml for 173\~174cm, 2.225 ml for 170\~172cm, 2.15 0ml for 168\~169cm, 2.075 ml for 165\~167cm, 2.000 ml for 163\~164cm, 1.925 ml for 160\~162cm, 1.850 ml for 158\~159cm, 1.775 ml for 155\~157cm, 1.700 ml for 153\~154cm, 1.625 ml for 150\~152cm, 1.55 0ml for 148\~149cm, 1.475 ml for 145\~147cm)

06

What researchers measure

Primary outcomes

  1. Incidence of hypotension after anesthesia

    Hypotension after anesthesia expressed in number of patients with one or more episodes of hypotension (Systolic blood pressure \< 90 mmHg or 70% of baseline value) up to fetal delivery.

    Time frame: delivery

07

Study locations

1 of 1 sites recruiting
  • ShenZhen People's Hospital of Jinan University
    Shenzhen, Guangdong 518020, China
    Recruiting
08

References and documents

Publications

  • Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022. PubMed 35755061 ↗
  • Huang B, Huang Q, Hai C, Zheng Z, Li Y, Zhang Z. Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2019 May 16;9(5):e024912. doi: 10.1136/bmjopen-2018-024912. PubMed 31101694 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2018 (actual). Primary completion is estimated for Nov 2021, 42 months after the start.

Of 210 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's planned 42 months is above that.

Counting every sponsor, half of 217 studies reached it within 12 months; a quarter within 6 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2018
First posted
Apr 13, 2018
StartActual
May 1, 2018
Primary completionEst.
Nov 30, 2021
CompletionEst.
Nov 30, 2021
Last update
Nov 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03497364
Lead sponsor
Shenzhen People's Hospital
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
May 1, 2018
Primary completion
Nov 30, 2021 (estimated)
Completion
Nov 30, 2021 (estimated)
Last update
Nov 18, 2020

Study contacts

Bowan Huang, docter
Contact
285021731@qq.com
+86 755-25533018
Zhongjun Zhang, master
study director · ShenZhen People's Hospital of Jinan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Bupivacaine · Ropivacaine

Start the discussion