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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: transversus abdominis plane block; Procedure: Patient controlled analgesia; Procedure: local infiltration

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block; 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; bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia; Procedure: Patient controlled analgesia; postoperative analgesia with intravenous patient controlled analgesia with morphine
Active Comparator: Local infiltration; 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: Patient controlled analgesia; postoperative analgesia with intravenous patient controlled analgesia with morphine; Procedure: local infiltration; local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure; Other Names: local anesthetics infiltration
Active Comparator: PCA only; 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; postoperative analgesia with intravenous patient controlled analgesia with morphine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Principal Investigator: Chuen-Chau Chang, PhD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 5, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 24, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: ropivacaine; transversus abdominis plane block; local infiltration; postoperative analgesia; heart rate variability
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 201309028