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Status unknownNCT02595333Updated Nov 3, 2015

Incision Pain and Uterine Contraction Pain After Cesarean Section

An interventional study of Group SF1 and Group S1 in C.Delivery; Surgery (Previous), Gynecological, sponsored by Fudan University. Status unknown. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study aims to compare the pain degree between primary cesarean section and repeated cesarean section, and investigate the role of flurbiprofen axetil in postoperative analgesia, so as to provide reference for clinical practice.

Read the detailed description

No premedication was given. The temperature of the operating room was maintained at 22˚ C. Patients were positioned supine with 15° left lateral tilt achieved using a wedge under the right buttock. Electrocardiograph(ECG), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were monitored by one anesthesiologist (S/5 Anesthesia Monitor, GE Healthcare, Helsinki, Finland). Peripheral vein catheterization on the right hand was then performed, but no prehydration was given. A fixed volume of 500 ml hydroxyethyl starch solution was infused at the rate of 0.2 ml•kg-1•min-1, then Lactated Ringer's solution was infused at the same rate to the end of surgery. Combined spinal-epidural anesthesia was administered with patients in the left lateral position at the L3-4 vertebral interspace. A 16-gauge Tuohy needle was placed in the epidural space using loss of resistance to saline, then a 25-gauge Whitacre spinal needle was inserted through the Tuohy needle until the dura mater was punctured. Once free flow of clear cerebrospinal fluid (CSF) was observed in the spinal needle, 10 mg (2 mL) of isobaric bupivacaine 0.5% was diluted with CSF to 2.5 mL, then injected over 15-30 s. After placement and fixation of an epidural catheter, the patients were positioned supine with 15° left lateral tilt, and oxygen was given via nasal catheter at 2L.min-1. The sensory block level to cold was monitored every three minutes (1, 4, 7 and 10 min) with alcohol swabs and was recorded at the time point of 10 min. Hypotension was defined as SBP lower than 80% of the baseline value, and was treated with intravenous phenylephrine 100 µg as required. Intravenous atropine 0.3 mg was given for severe sinus bradycardia (HR \< 50 beats/min). Surgery was allowed to start after the sensory block reached the T6 level; if this level was not achieved, patients were excluded from the study. For patients with inadequate sensory block, 1.5% lidocaine was given through the epidural catheter.

Four groups were divided based on surgical types and postoperative analgesia regimens, with 20 cases in each group: primary cesarean section + postoperative analgesia with sufentanil plus flurbiprofen axetil group(Group SF1), primary cesarean section+postoperative analgesia with sufentanil group (Group S1), repeated cesarean Section + postoperative analgesia with sufentanil plus flurbiprofen axetil group(Group SF2), and repeated cesarean section+ postoperative analgesia with sufentanil group(Group S2). Analgesia regimen: PCIA,100 ml; sufentanil 100 ug, ramosetron 0.3 mg, flurbiprofen axetil 100 mg (varied in groups); backgroup dosage 2 ml/h, PCA 2 ml each time, lock time 20 min. The scores of incision pain and uterine contraction pain 24 h, 48 h and 72 h after operation and the dose and pumping times of analgesia pump 24 h after operation were recorded.

02

Conditions studied

  • C.Delivery; Surgery (Previous), Gynecological

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Keywords

  • repeat cesarean section
  • pain
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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Inclusion criteria

  • Eighty women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

Exclusion criteria

Exclusion Criteria:

  • Diabetes controlled by insulin
  • Preeclampsia
  • Heart diseases
  • History of taking drugs potentially affecting cardiovascular system.
  • Patients fasted for at least 8 hours before surgery and no premedication was given
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Group SF1

    primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

    Drug: Group SF1

  • Experimental
    Group S1

    primary cesarean section+postoperative analgesia with sufentanil group

    Drug: Group S1

  • Experimental
    Group SF2

    repeated cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

    Drug: Group SF2

  • Experimental
    Group S2

    repeated cesarean section+postoperative analgesia with sufentanil group

    Drug: Group S2

Interventions

  • DrugGroup SF1

    primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group

    Also known as: 1

  • DrugGroup S1

    sufentanil was administered for analgesia in primary cesarean section

    Also known as: 2

  • DrugGroup SF2

    sufentanil and flurbiprofen was administered for analgesia in repeated cesarean section

    Also known as: 3

  • DrugGroup S2

    sufentanil was administered for analgesia in repeated cesarean section

    Also known as: 4

06

What researchers measure

Primary outcomes

  1. The scores of incision pain and uterine contraction pain 24 h, 48 h and 72 h after operation

    Time frame: up to 24 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2015, a primary completion of Aug 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

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

Registered
Oct 26, 2015
First posted
Nov 3, 2015
Start
Nov 2015
Primary completionEst.
Aug 2017
CompletionEst.
Dec 2017
Last update
Nov 3, 2015
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 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02595333
Lead sponsor
Fudan University
Responsible party
Tingting Wang (Obstetrics and Gynecology Hospital, Fudan University) — Principal investigator
First posted
Nov 3, 2015
Start date
Nov 2015
Primary completion
Aug 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Nov 3, 2015

Study contacts

Shen Sun
Contact
sunshen1980@126.com
Shaoqiang Huang
study director · Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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