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Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery (TAP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
transversus abdominis plane block
local infiltration
Patient controlled analgesia
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (20~65y/o)
  • American Society of Anesthesiologists (ASA) physical status I~II
  • Patients scheduled for regular abdominal surgery under general anesthesia

Exclusion Criteria:

  • ASA physical status ≥ 3
  • Allergy to morphine or local anesthetics
  • Morphine tolerance
  • Drug abuse or addiction
  • Bleeding tendency

Sites / Locations

  • Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

TAP block

Local infiltration

PCA only

Arm Description

postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.

postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.

postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.

Outcomes

Primary Outcome Measures

Pain Score (NRS: Numerical Rating Scale)
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Opioid Consumption
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).

Secondary Outcome Measures

Sedation Scale
Nausea and Vomiting Categorical Score
Rescue Analgesic Use
Rescue Antiemetics Use
Time to the First Request of Analgesics
participants will be followed for the duration of hospital stay
Pruritus
Quality of Recovery 40
Heart Rate Variability
Time to Flatus
participants will be followed for the duration of hospital stay
Length of Hospital Stay
participants will be followed for the duration of hospital stay
Number of Participants With Intervention-related Complication
participants will be followed for the duration of hospital stay

Full Information

First Posted
January 5, 2014
Last Updated
May 24, 2015
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02029755
Brief Title
Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery
Acronym
TAP
Official Title
Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery. For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear. This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Experimental
Arm Description
postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Arm Title
Local infiltration
Arm Type
Active Comparator
Arm Description
postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Arm Title
PCA only
Arm Type
Active Comparator
Arm Description
postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Intervention Type
Procedure
Intervention Name(s)
transversus abdominis plane block
Intervention Description
bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
local infiltration
Other Intervention Name(s)
local anesthetics infiltration
Intervention Description
local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Intervention Type
Procedure
Intervention Name(s)
Patient controlled analgesia
Intervention Description
postoperative analgesia with intravenous patient controlled analgesia with morphine
Primary Outcome Measure Information:
Title
Pain Score (NRS: Numerical Rating Scale)
Description
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Time Frame
postoperative 24 hour dynamic
Title
Opioid Consumption
Description
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Time Frame
postoperative 48 hour
Secondary Outcome Measure Information:
Title
Sedation Scale
Time Frame
postoperative 1, 6, 24, 48 hour
Title
Nausea and Vomiting Categorical Score
Time Frame
postoperative 1, 6, 24, 48 hour
Title
Rescue Analgesic Use
Time Frame
postoperative 1, 6, 12, 24, 36, 48 hour
Title
Rescue Antiemetics Use
Time Frame
postoperative 1, 6, 12, 24, 36, 48 hour
Title
Time to the First Request of Analgesics
Description
participants will be followed for the duration of hospital stay
Time Frame
an expected average of 5 days
Title
Pruritus
Time Frame
postoperative 1, 6, 24, 48 hour
Title
Quality of Recovery 40
Time Frame
postoperative 48 hour
Title
Heart Rate Variability
Time Frame
preoperative, postoperative 1 hour and 1 day
Title
Time to Flatus
Description
participants will be followed for the duration of hospital stay
Time Frame
an expected average of 5 days
Title
Length of Hospital Stay
Description
participants will be followed for the duration of hospital stay
Time Frame
an expected average of 5 days
Title
Number of Participants With Intervention-related Complication
Description
participants will be followed for the duration of hospital stay
Time Frame
an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (20~65y/o) American Society of Anesthesiologists (ASA) physical status I~II Patients scheduled for regular abdominal surgery under general anesthesia Exclusion Criteria: ASA physical status ≥ 3 Allergy to morphine or local anesthetics Morphine tolerance Drug abuse or addiction Bleeding tendency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuen-Chau Chang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery

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