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Completed

NCT Number: NCT02029755

Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for 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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Taiwan, 110

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

local infiltration

Procedure

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

Other names: local anesthetics infiltration

Patient controlled analgesia

Procedure

postoperative analgesia with intravenous patient controlled analgesia with morphine

Primary outcomes

  1. Pain Score (NRS: Numerical Rating Scale)

    Time frame: postoperative 24 hour dynamic

    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.

  2. Opioid Consumption

    Time frame: postoperative 48 hour

    opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).

Secondary outcomes

  1. Sedation Scale

    Time frame: postoperative 1, 6, 24, 48 hour

  2. Nausea and Vomiting Categorical Score

    Time frame: postoperative 1, 6, 24, 48 hour

  3. Rescue Analgesic Use

    Time frame: postoperative 1, 6, 12, 24, 36, 48 hour

  4. Rescue Antiemetics Use

    Time frame: postoperative 1, 6, 12, 24, 36, 48 hour

  5. Time to the First Request of Analgesics

    Time frame: an expected average of 5 days

    participants will be followed for the duration of hospital stay

  6. Pruritus

    Time frame: postoperative 1, 6, 24, 48 hour

  7. Quality of Recovery 40

    Time frame: postoperative 48 hour

  8. Heart Rate Variability

    Time frame: preoperative, postoperative 1 hour and 1 day

  9. Time to Flatus

    Time frame: an expected average of 5 days

    participants will be followed for the duration of hospital stay

  10. Length of Hospital Stay

    Time frame: an expected average of 5 days

    participants will be followed for the duration of hospital stay

  11. Number of Participants With Intervention-related Complication

    Time frame: an expected average of 5 days

    participants will be followed for the duration of hospital stay

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

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

Acronym: TAP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2014
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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