Incision Pain and Uterine Contraction Pain After Cesarean Section

November 2, 2015 updated by: Tingting Wang, Fudan University

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group SF1
primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
Other Names:
  • 1
EXPERIMENTAL: Group S1
primary cesarean section+postoperative analgesia with sufentanil group
sufentanil was administered for analgesia in primary cesarean section
Other Names:
  • 2
EXPERIMENTAL: Group SF2
repeated cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
sufentanil and flurbiprofen was administered for analgesia in repeated cesarean section
Other Names:
  • 3
EXPERIMENTAL: Group S2
repeated cesarean section+postoperative analgesia with sufentanil group
sufentanil was administered for analgesia in repeated cesarean section
Other Names:
  • 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The scores of incision pain and uterine contraction pain 24 h, 48 h and 72 h after operation
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 3, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • TT-Wang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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