Clinical trial NCT02029755: Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: transversus abdominis plane block
local infiltration
ropivacaine
heart rate variability
postoperative analgesia
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain Score (NRS: Numerical Rating Scale)
timeFrame: postoperative 24 hour dynamic
measure: Opioid Consumption
timeFrame: postoperative 48 hour
Secondary outcomes:
measure: Sedation Scale
timeFrame: postoperative 1, 6, 24, 48 hour
measure: Nausea and Vomiting Categorical Score
timeFrame: postoperative 1, 6, 24, 48 hour
measure: Rescue Analgesic Use
timeFrame: postoperative 1, 6, 12, 24, 36, 48 hour
measure: Rescue Antiemetics Use
timeFrame: postoperative 1, 6, 12, 24, 36, 48 hour
measure: Time to the First Request of Analgesics
timeFrame: an expected average of 5 days
measure: Pruritus
timeFrame: postoperative 1, 6, 24, 48 hour
measure: Quality of Recovery 40
timeFrame: postoperative 48 hour
measure: Heart Rate Variability
timeFrame: preoperative, postoperative 1 hour and 1 day
measure: Time to Flatus
timeFrame: an expected average of 5 days
measure: Length of Hospital Stay
timeFrame: an expected average of 5 days
measure: Number of Participants With Intervention-related Complication
timeFrame: an expected average of 5 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University
name: Chuen-Chau Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: