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Comparison of Anesthesia Type in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)

Primary Purpose

Cervical Incompetence

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bupivacaine Hcl 0.5% Inj
Propofol 10 milligram/ML
Sponsored by
Hallym University Kangnam Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Incompetence

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who undergo TCIC for IIOC and agree to participate in this study.

Exclusion Criteria:

  • Hepatic failure
  • Chronic kidney disease(>stage III)
  • Hypersensitivity, allergic response and/or resistance to drugs used in this study(ex. pethidine, ropivacaine)
  • Spinal anesthesia is not possible
  • Refuse to participate in the study
  • Cannot understand the agreement
  • Body weight is under 50 kg or over 100 kg

Sites / Locations

  • Kangnam sungshim hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal anesthesia group

General anesthesia group

Arm Description

Spinal anesthesia is used for operation with epidural patient-controlled device for pain control. Bupivacaine Hcl 0.5% Inj. 9-10mg is injected into intrathecal space for anesthesia. 0.2% ropivacaine is used for postoperative pain control with continuous infusion into epidural space.

General anesthesia is used for operation with wound patient-controlled device for pain control. propofol (10milligram/ML) 1.5-2 mg/ml is used as bolus intravascular injection for induction of anesthesia. 0.5% ropivacaine is used for postoperative pain control with continous infusion through wound catheter.

Outcomes

Primary Outcome Measures

Pain score at 24hours after the end of the operation
Numerical Rating Score(0-10), 0:no pain, 5:moderate pain, 10:worst pain

Secondary Outcome Measures

Fetal viability on postoperative day 5
An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.

Full Information

First Posted
August 1, 2018
Last Updated
September 2, 2020
Sponsor
Hallym University Kangnam Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03636048
Brief Title
Comparison of Anesthesia Type in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)
Official Title
Comparison of General Anesthesia and Combined Spinal-epidural Anesthesia on Postoperative Outcomes in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
not enough participants
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigator aimed to compare the effect of anesthesia on overall postoperative outcomes including post-operative pain score and the fetal well-being (heart rate) in patients undergoing transabdominal cervico isthmic cerclage(TCIC). The investigator divided the patients into two groups. The first group was the patients who undergo general anesthesia with postoperative wound patient-controlled analgesia device(PCA) and the second group was the patients who undergo combined spinal-epidural anesthesia(CSE) with postoperative epidural catheter PCA device for pain control.
Detailed Description
Transabdominal cervico isthmic cerclage(TCIC) is performed for the pregnants with Incompetent Internal Os of the Cervix(IIOC) to maintain pregnancy. It is the operation that incise the lower abdomen and ligate the cervix in pelvic cavity. In our center, the surgery was conventionally performed under general anesthesia. Also, for pain control, operator has been inserting a catheter into the incision site and connected the wound PCA. In this way, there were some limitations that the wound PCA could only control the somatic pain and there were significant rates of post-operative nausea and vomiting as common complication of general anesthesia. Thus, the investigator planned to conduct combined spinal-epidural anesthesia(CSE) with postoperative pain control with epidural catheter and compare overall postoperative outcomes with conventional general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Incompetence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal anesthesia group
Arm Type
Experimental
Arm Description
Spinal anesthesia is used for operation with epidural patient-controlled device for pain control. Bupivacaine Hcl 0.5% Inj. 9-10mg is injected into intrathecal space for anesthesia. 0.2% ropivacaine is used for postoperative pain control with continuous infusion into epidural space.
Arm Title
General anesthesia group
Arm Type
Active Comparator
Arm Description
General anesthesia is used for operation with wound patient-controlled device for pain control. propofol (10milligram/ML) 1.5-2 mg/ml is used as bolus intravascular injection for induction of anesthesia. 0.5% ropivacaine is used for postoperative pain control with continous infusion through wound catheter.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.5% Inj
Other Intervention Name(s)
Spinal anesthesia with epidural patient-controlled analgesia
Intervention Description
The patients undergo surgery under spinal anesthesia and a catheter would be inserted into epidural space during the procedure. 0.5% bupivacaine is injected into intrathecal space for spinal anesthesia. For pain control, 0.2% ropivacaine is continuously infused into epidural space postoperatively.
Intervention Type
Drug
Intervention Name(s)
Propofol 10 milligram/ML
Other Intervention Name(s)
general anesthesia with wound patient-controlled analgesia
Intervention Description
The patients undergo surgery under general anesthesia and a catheter would be inserted to abdominal incision site at the end of the operation. Propofol is used for induction of general anesthesia, and sevoflurane is used for maintenance of anesthesia. At the end of the operation, the surgeon inserts wound catheter in the surgical site and connects wound patient-controlled analgesia device filled with 0.5% ropivacaine.
Primary Outcome Measure Information:
Title
Pain score at 24hours after the end of the operation
Description
Numerical Rating Score(0-10), 0:no pain, 5:moderate pain, 10:worst pain
Time Frame
Assessed by directly asking to the patient, from date of randomization up to postoperative day 3.
Secondary Outcome Measure Information:
Title
Fetal viability on postoperative day 5
Description
An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.
Time Frame
Assessed by ultrasonography, upto postoperative day 5.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who undergo TCIC for IIOC and agree to participate in this study. Exclusion Criteria: Hepatic failure Chronic kidney disease(>stage III) Hypersensitivity, allergic response and/or resistance to drugs used in this study(ex. pethidine, ropivacaine) Spinal anesthesia is not possible Refuse to participate in the study Cannot understand the agreement Body weight is under 50 kg or over 100 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunmi Choi, MD.PhD
Organizational Affiliation
Kangnam sungshim hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangnam sungshim hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparison of Anesthesia Type in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)

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