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

September 2, 2020 updated by: Hallym University Kangnam Sacred Heart Hospital

Comparison of General Anesthesia and Combined Spinal-epidural Anesthesia on Postoperative Outcomes in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spinal anesthesia group
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.
Drug: Bupivacaine Hcl 0.5% Inj
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.
Other Names:
  • Spinal anesthesia with epidural patient-controlled analgesia
ACTIVE_COMPARATOR: General anesthesia group
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.
Drug: Propofol 10 milligram/ML
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.
Other Names:
  • general anesthesia with wound patient-controlled analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score at 24hours after the end of the operation
Time Frame: Assessed by directly asking to the patient, from date of randomization up to postoperative day 3.
Numerical Rating Score(0-10), 0:no pain, 5:moderate pain, 10:worst pain
Assessed by directly asking to the patient, from date of randomization up to postoperative day 3.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal viability on postoperative day 5
Time Frame: Assessed by ultrasonography, upto postoperative day 5.
An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.
Assessed by ultrasonography, upto postoperative day 5.

Collaborators and Investigators

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

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Investigators

  • Study Chair: Eunmi Choi, MD.PhD, Kangnam Sungshim Hospital

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 (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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