Cervical Incompetence
Conditions
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.
Interventions
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.
DRUGPropofol 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.
Sponsors
Hallym University Kangnam Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Fetal viability on postoperative day 5 | Assessed by ultrasonography, upto postoperative day 5. | An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph. |
Countries
South Korea
Outcome results
None listed