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

Not Applicable

Terminated

• Conditions: Cervical Incompetence
• Interventions: Drug: Propofol 10 milligram/ML; Drug: Bupivacaine Hcl 0.5% Inj

• Registration Number: NCT03636048
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2020-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia group	Propofol 10 milligram/ML	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.
Spinal anesthesia group	Bupivacaine Hcl 0.5% Inj	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.

Primary Outcome Measures

Name	Time	Method
Pain score at 24hours after the end of the operation	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

Secondary Outcome Measures

Name	Time	Method
Fetal viability on postoperative day 5	Assessed by ultrasonography, upto postoperative day 5.	An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.

Trial Locations

Locations (1)

Kangnam sungshim hospital; 🇰🇷 Seoul, Korea, Republic of