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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
Sponsor:
Information provided by (Responsible Party):
Hallym University Kangnam Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Incompetence Drug: Bupivacaine Hcl 0.5% Inj Drug: Propofol 10 milligram/ML Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: InJung Jun, MD 82-10-9312-0162 christine17@hanmail.net

Locations
Korea, Republic of
Kangnam sungshim hospital Recruiting
Seoul, Korea, Republic of
Contact: Jun In-Jung, fellow         
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
Study Chair: Eunmi Choi, MD.PhD Kangnam sungshim hospital

Responsible Party: Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03636048     History of Changes
Other Study ID Numbers: 2018-05-013
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Cervical Incompetence
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Anesthetics
Bupivacaine
Propofol
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General