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

Cervical Incompetence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03636048
• Other study ID #: 2018-05-013
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Incompetence
• Uterine Cervical Incompetence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sungshim hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score at 24hours after the end of the operation	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	Fetal viability on postoperative day 5	An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.	Assessed by ultrasonography, upto postoperative day 5.