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

NCT ID: NCT03636048

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-06-01

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.

Conditions

Cervical Incompetence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine Hcl 0.5% Inj

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Propofol 10 milligram/ML

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Spinal anesthesia with epidural patient-controlled analgesia; general anesthesia with wound patient-controlled analgesia

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eunmi Choi, MD.PhD

Role: STUDY_CHAIR

Kangnam sungshim hospital

Locations

Kangnam sungshim hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2018-05-013

Identifier Type: -

Identifier Source: org_study_id