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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: transversus abdominis plane block
* Procedure: local infiltration
* Procedure: Patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block<br>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. | Procedure: transversus abdominis plane block<br>* bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia<br>Procedure: Patient controlled analgesia<br>* postoperative analgesia with intravenous patient controlled analgesia with morphine<br>|
| Active Comparator: Local infiltration<br>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. | Procedure: local infiltration<br>* local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure<br>* Other names: local anesthetics infiltration;Procedure: Patient controlled analgesia<br>* postoperative analgesia with intravenous patient controlled analgesia with morphine<br>|
| Active Comparator: PCA only<br>postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. | Procedure: Patient controlled analgesia<br>* postoperative analgesia with intravenous patient controlled analgesia with morphine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | postoperative 24 hour dynamic | 
| Opioid Consumption | opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours). | postoperative 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Scale |  | postoperative 1, 6, 24, 48 hour | 
| Nausea and Vomiting Categorical Score |  | postoperative 1, 6, 24, 48 hour | 
| Rescue Analgesic Use |  | postoperative 1, 6, 12, 24, 36, 48 hour | 
| Rescue Antiemetics Use |  | postoperative 1, 6, 12, 24, 36, 48 hour | 
| Time to the First Request of Analgesics | participants will be followed for the duration of hospital stay | an expected average of 5 days | 
| Pruritus |  | postoperative 1, 6, 24, 48 hour | 
| Quality of Recovery 40 |  | postoperative 48 hour | 
| Heart Rate Variability |  | preoperative, postoperative 1 hour and 1 day | 
| Time to Flatus | participants will be followed for the duration of hospital stay | an expected average of 5 days | 
| Length of Hospital Stay | participants will be followed for the duration of hospital stay | an expected average of 5 days | 
| Number of Participants With Intervention-related Complication | participants will be followed for the duration of hospital stay | an expected average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia