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

NCT03636048 | Terminated

• 1 other identifier: 2018-05-013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Incompetence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fetal viability on postoperative day 5

  Assessed by ultrasonography, upto postoperative day 5.

Study Arms (2)

Spinal anesthesia group

EXPERIMENTAL

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

General anesthesia group

ACTIVE COMPARATOR

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

Interventions

Bupivacaine Hcl 0.5% Inj DRUG

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.

Also known as: Spinal anesthesia with epidural patient-controlled analgesia

Spinal anesthesia group

Propofol 10 milligram/ML DRUG

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.

Also known as: general anesthesia with wound patient-controlled analgesia

General anesthesia group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who undergo TCIC for IIOC and agree to participate in this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam sungshim hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Incompetence

Interventions

Bupivacaine; Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Eunmi Choi, MD.PhD

  Kangnam sungshim hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 17, 2018
• Study Start: August 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-01

Locations

KR (1)