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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Taipei Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
hsiao chien tsai, Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT02029755
First received: January 5, 2014
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Postoperative Pain
Procedure: transversus abdominis plane block
Procedure: local infiltration
Procedure: Patient controlled analgesia

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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: postoperative 48 hour ] [ Designated as safety issue: No ]
    pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).

  • opioid consumption [ Time Frame: postoperative 48 hour ] [ Designated as safety issue: Yes ]
    opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).


Secondary Outcome Measures:
  • sedation scale [ Time Frame: postoperative 1, 6, 24, 48 hour ] [ Designated as safety issue: No ]
  • nausea and vomiting categorical score [ Time Frame: postoperative 1, 6, 24, 48 hour ] [ Designated as safety issue: No ]
  • rescue analgesic use [ Time Frame: postoperative 1, 6, 12, 24, 36, 48 hour ] [ Designated as safety issue: Yes ]
  • rescue antiemetics use [ Time Frame: postoperative 1, 6, 12, 24, 36, 48 hour ] [ Designated as safety issue: Yes ]
  • time to the first request of analgesics [ Time Frame: an expected average of 5 days ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay

  • pruritus [ Time Frame: postoperative 1, 6, 24, 48 hour ] [ Designated as safety issue: No ]
  • quality of recovery 40 [ Time Frame: postoperative 48 hour ] [ Designated as safety issue: No ]
  • heart rate variability [ Time Frame: preoperative, postoperative 1 hour and 1 day ] [ Designated as safety issue: No ]
  • time to flatus [ Time Frame: an expected average of 5 days ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay

  • length of hospital stay [ Time Frame: an expected average of 5 days ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay

  • number of participants with intervention-related complication [ Time Frame: an expected average of 5 days ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay


Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: transversus abdominis plane block
Procedure: Patient controlled analgesia
postoperative analgesia with intravenous patient controlled analgesia with morphine
Other Name: patient controlled analgesia
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: local infiltration
local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Other Name: local anesthetics infiltration
Procedure: Patient controlled analgesia
postoperative analgesia with intravenous patient controlled analgesia with morphine
Other Name: patient controlled analgesia
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
Other Name: patient controlled analgesia

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029755

Contacts
Contact: Hsiao-Chie Tsai, MD +886-2-27372181 ext 8310 hctsai.anes@gmail.com
Contact: Chuen-Chau Chang, PhD +886-2-27372181 ext 8310 nekota@tmu.edu.tw

Locations
Taiwan
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Chuen-Chau Chang, PhD    +886-2-27372181 ext 8310      
Sub-Investigator: Hsiao-Chien Tsai, MD         
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Chuen-Chau Chang, PhD Taipei Medical University
  More Information

No publications provided

Responsible Party: hsiao chien tsai, fellow researcher, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02029755     History of Changes
Other Study ID Numbers: 201309028
Study First Received: January 5, 2014
Last Updated: January 8, 2014
Health Authority: Taiwan : Food and Drug Administration
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: Ministry of Health and Welfare
Taiwan: National Bureau of Controlled Drugs
Taiwan: National Health Research Institutes
Taiwan: National Science Council
Taiwan: Research Ethics Committee

Keywords provided by Taipei Medical University Hospital:
transversus abdominis plane block
local infiltration
ropivacaine
heart rate variability
postoperative analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014