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

NCT ID: NCT02029755

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

transversus abdominis plane block

Intervention Type: PROCEDURE

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

Patient controlled analgesia

Intervention Type: PROCEDURE

postoperative analgesia with intravenous patient controlled analgesia with morphine

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.

Group Type: ACTIVE_COMPARATOR

local infiltration

Intervention Type: PROCEDURE

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

Patient controlled analgesia

Intervention Type: PROCEDURE

postoperative analgesia with intravenous patient controlled analgesia with morphine

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.

Group Type: ACTIVE_COMPARATOR

Patient controlled analgesia

Intervention Type: PROCEDURE

postoperative analgesia with intravenous patient controlled analgesia with morphine

Interventions

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

Intervention Type: PROCEDURE

local infiltration

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

Intervention Type: PROCEDURE

Patient controlled analgesia

postoperative analgesia with intravenous patient controlled analgesia with morphine

Intervention Type: PROCEDURE

Other Intervention Names

local anesthetics infiltration

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hsiao chien tsai

fellow researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chuen-Chau Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

201309028

Identifier Type: -

Identifier Source: org_study_id