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

NCT02029755 | Completed Results DMC

• 1 other identifier: 201309028
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

transversus abdominis plane block; local infiltration; ropivacaine; heart rate variability; postoperative analgesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

  an expected average of 5 days

Study Arms (3)

TAP block

EXPERIMENTAL

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; Procedure: Patient controlled analgesia

Local infiltration

ACTIVE COMPARATOR

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; Procedure: Patient controlled analgesia

PCA only

ACTIVE COMPARATOR

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

Interventions

transversus abdominis plane block PROCEDURE

bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia

TAP block

local infiltration PROCEDURE

local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure

Also known as: local anesthetics infiltration

Local infiltration

Patient controlled analgesia PROCEDURE

postoperative analgesia with intravenous patient controlled analgesia with morphine

Local infiltration; PCA only; TAP block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (20\~65y/o)
• American Society of Anesthesiologists (ASA) physical status I\~II
• Patients scheduled for regular abdominal surgery under general anesthesia

You may not qualify if:

• ASA physical status ≥ 3
• Allergy to morphine or local anesthetics
• Morphine tolerance
• Drug abuse or addiction
• Bleeding tendency

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan, 110, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Analgesia

Results Point of Contact

• Title: Dr. Hsiao-Chien Tsai
• Organization: Taipei medical university hospital

hctsai.anes@gmail.com

+886-2-27372181

Study Officials

• Chuen-Chau Chang, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow researcher

Study Record Dates

• First Submitted: January 5, 2014
• First Posted: January 8, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05

Locations

TW (1)