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C.Delivery; Surgery (Previous), GynecologicalNCT02595333

Incision Pain and Uterine Contraction Pain After Cesarean Section

A study testing Group SF1, Group S1 and Group SF2 in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Group SF1, Group S1 and Group SF2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Nov 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Shen Sun contact

sunshen1980@126.com

About this study

Official title: Differences in Incision Pain and Uterine Contraction Pain After Cesarean Section Between Primary Section and Repeat Section

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.

Being tested
Group SF1, Group S1, Group SF2, Group S2
Keywords
repeat cesarean section, pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group SF1Drug

    Also called 1

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

  • Group S1Drug

    Also called 2

    sufentanil was administered for analgesia in primary cesarean section

  • Group SF2Drug

    Also called 3

    sufentanil and flurbiprofen was administered for analgesia in repeated cesarean section

  • Group S2Drug

    Also called 4

    sufentanil was administered for analgesia in repeated cesarean section

Study groups in NCT02595333
Study groupRoleWhat they receive
Group SF1Experimentalprimary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
Receives: Drug: Group SF1
Group S1Experimentalprimary cesarean section+postoperative analgesia with sufentanil group
Receives: Drug: Group S1
Group SF2Experimentalrepeated cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
Receives: Drug: Group SF2
Group S2Experimentalrepeated cesarean section+postoperative analgesia with sufentanil group
Receives: Drug: Group S2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02595333
Sponsor's protocol ID
TT-Wang
Status last verified
Oct 2015
First submitted
26 Oct 2015
Last updated
3 Nov 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Group SF1, Group S1 and Group SF2 in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shen Sun (sunshen1980@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The scores of incision pain and uterine contraction pain 24 h, 48 h and 72 h after operation (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.

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