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

Postoperative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029755
• Other study ID #: 201309028
• Status: Completed
• Phase: N/A
• First received: January 5, 2014
• Last updated: May 24, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug AdministrationTaiwan: Center for Drug EvaluationTaiwan: Department of HealthTaiwan: Institutional Review BoardTaiwan: Ministry of Health and WelfareTaiwan: National Bureau of Controlled DrugsTaiwan: National Health Research InstitutesTaiwan: National Science CouncilTaiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• local infiltration
local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
• Patient controlled analgesia
postoperative analgesia with intravenous patient controlled analgesia with morphine

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Sedation Scale		postoperative 1, 6, 24, 48 hour	No
Secondary	Nausea and Vomiting Categorical Score		postoperative 1, 6, 24, 48 hour	No
Secondary	Rescue Analgesic Use		postoperative 1, 6, 12, 24, 36, 48 hour	Yes
Secondary	Rescue Antiemetics Use		postoperative 1, 6, 12, 24, 36, 48 hour	Yes
Secondary	Time to the First Request of Analgesics	participants will be followed for the duration of hospital stay	an expected average of 5 days	No
Secondary	Pruritus		postoperative 1, 6, 24, 48 hour	No
Secondary	Quality of Recovery 40		postoperative 48 hour	No
Secondary	Heart Rate Variability		preoperative, postoperative 1 hour and 1 day	No
Secondary	Time to Flatus	participants will be followed for the duration of hospital stay	an expected average of 5 days	No
Secondary	Length of Hospital Stay	participants will be followed for the duration of hospital stay	an expected average of 5 days	No
Secondary	Number of Participants With Intervention-related Complication	participants will be followed for the duration of hospital stay	an expected average of 5 days	Yes