Comparison of Anesthesia Type in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)
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|ClinicalTrials.gov Identifier: NCT03636048|
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Incompetence||Drug: Bupivacaine Hcl 0.5% Inj Drug: Propofol 10 milligram/ML||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of General Anesthesia and Combined Spinal-epidural Anesthesia on Postoperative Outcomes in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 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.
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.
Other Name: Spinal anesthesia with epidural patient-controlled analgesia
Active Comparator: 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.
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.
Other Name: general anesthesia with wound patient-controlled analgesia
- Pain score at 24hours after the end of the operation [ Time Frame: 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
- Fetal viability on postoperative day 5 [ Time Frame: Assessed by ultrasonography, upto postoperative day 5. ]An obstetrician evaluates fetal viability(fetal heart rate) using ultrasonograph.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636048
|Contact: InJung Jun, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Kangnam sungshim hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Jun In-Jung, fellow|
|Study Chair:||Eunmi Choi, MD.PhD||Kangnam sungshim hospital|