Clinical trial NCT03636048: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Incompetence
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain score at 24hours after the end of the operation
timeFrame: Assessed by directly asking to the patient, from date of randomization up to postoperative day 3.
Secondary outcomes:
measure: Fetal viability on postoperative day 5
timeFrame: Assessed by ultrasonography, upto postoperative day 5.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam sungshim hospital
Study officials:
affiliation: Kangnam sungshim hospital
name: Eunmi Choi, MD.PhD
role: STUDY_CHAIR
References: