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

H

Hallym University Kangnam Sacred Heart Hospital

Status

Terminated

Conditions

Cervical Incompetence

Treatments

Drug: Propofol 10 milligram/ML
Drug: Bupivacaine Hcl 0.5% Inj

Study type

Interventional

Funder types

Other

Identifiers

NCT03636048
2018-05-013

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Spinal anesthesia group
Experimental group
Description:
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.
Treatment:
Drug: Bupivacaine Hcl 0.5% Inj
General anesthesia group
Active Comparator group
Description:
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.
Treatment:
Drug: Propofol 10 milligram/ML

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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