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The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section (TAP)

Primary Purpose

Obstetric Pain

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
TAP block
Morphine
Ropivacaine
Sponsored by
Gia Dinh People Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstetric Pain focused on measuring transversus abdominis plane block (TAP block), postoperative analgesia, cesarean section

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Cesarean section with general anesthesia.
  • The ASA classification was from II to III

Exclusion Criteria:

  • The acute fetal impairment.
  • The severe live or renal failure.
  • Tolerance opioids

Sites / Locations

  • THANG Nguyen Trong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

T group

C group

Arm Description

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia

Outcomes

Primary Outcome Measures

Total morphine consumption during 24 hours
Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).

Secondary Outcome Measures

The time required the first of dose of morphine (hours)
The time was from the end of surgery to the participants required the first of dose of morphine with PCA.
Pain score: VAS
Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain
The rate of complications of TAP block
There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
The rate of side effect of morphine
There were rate of sedation, respiratory failure, nause and vomiting, pruritus
The satisfaction of participants: Likert
It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree

Full Information

First Posted
August 12, 2018
Last Updated
August 14, 2018
Sponsor
Gia Dinh People Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03634111
Brief Title
The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section
Acronym
TAP
Official Title
The Transversus Abdominis Plane Block
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gia Dinh People Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.
Detailed Description
This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Pain
Keywords
transversus abdominis plane block (TAP block), postoperative analgesia, cesarean section

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Transversus abdominis plane block under the ultrasound guidance
Masking
None (Open Label)
Masking Description
Participants were cesarean section with general anesthesia
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T group
Arm Type
Active Comparator
Arm Description
The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.
Arm Title
C group
Arm Type
Placebo Comparator
Arm Description
The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia
Intervention Type
Procedure
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus abdominis plane block
Intervention Description
TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Opioids
Intervention Description
Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Anaropin
Intervention Description
Ropivacaine 0.25% 20 ml each side
Primary Outcome Measure Information:
Title
Total morphine consumption during 24 hours
Description
Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The time required the first of dose of morphine (hours)
Description
The time was from the end of surgery to the participants required the first of dose of morphine with PCA.
Time Frame
24 hours
Title
Pain score: VAS
Description
Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain
Time Frame
24 hours
Title
The rate of complications of TAP block
Description
There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
Time Frame
24 hours
Title
The rate of side effect of morphine
Description
There were rate of sedation, respiratory failure, nause and vomiting, pruritus
Time Frame
24 hours
Title
The satisfaction of participants: Likert
Description
It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cesarean section with general anesthesia. The ASA classification was from II to III Exclusion Criteria: The acute fetal impairment. The severe live or renal failure. Tolerance opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
THANG T Nguyen, Mr
Organizational Affiliation
Gia Dinh People Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
THANG Nguyen Trong
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section

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