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Clinical Trials/NCT02029755
NCT02029755
Completed
Not Applicable

Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery

Taipei Medical University Hospital1 site in 1 country108 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Taipei Medical University Hospital
Enrollment
108
Locations
1
Primary Endpoint
Opioid Consumption
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

hsiao chien tsai

fellow researcher

Taipei Medical University Hospital

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

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: postoperative 48 hour

opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).

Pain Score (NRS: Numerical Rating Scale)

Time Frame: postoperative 24 hour dynamic

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.

Secondary Outcomes

  • Sedation Scale(postoperative 1, 6, 24, 48 hour)
  • Nausea and Vomiting Categorical Score(postoperative 1, 6, 24, 48 hour)
  • Rescue Antiemetics Use(postoperative 1, 6, 12, 24, 36, 48 hour)
  • Time to the First Request of Analgesics(an expected average of 5 days)
  • Heart Rate Variability(preoperative, postoperative 1 hour and 1 day)
  • Length of Hospital Stay(an expected average of 5 days)
  • Rescue Analgesic Use(postoperative 1, 6, 12, 24, 36, 48 hour)
  • Time to Flatus(an expected average of 5 days)
  • Quality of Recovery 40(postoperative 48 hour)
  • Pruritus(postoperative 1, 6, 24, 48 hour)
  • Number of Participants With Intervention-related Complication(an expected average of 5 days)

Study Sites (1)

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