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Completed

NCT Number: NCT03634111

The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

THANG Nguyen Trong

Ho Chi Minh City, 700000, Vietnam

About this study

This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cesarean section with general anesthesia.
  • The ASA classification was from II to III

Exclusion criteria

  • The acute fetal impairment.
  • The severe live or renal failure.
  • Tolerance opioids

Treatment and study plan

TAP Block

Procedure

TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.

Other names: Transversus abdominis plane block

Morphine

Drug

Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.

Other names: Opioids

Ropivacaine

Drug

Ropivacaine 0.25% 20 ml each side

Other names: Anaropin

Primary outcomes

  1. Total morphine consumption during 24 hours

    Time frame: 24 hours

    Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).

Secondary outcomes

  1. The time required the first of dose of morphine (hours)

    Time frame: 24 hours

    The time was from the end of surgery to the participants required the first of dose of morphine with PCA.

  2. Pain score: VAS

    Time frame: 24 hours

    Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain

  3. The rate of complications of TAP block

    Time frame: 24 hours

    There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall

  4. The rate of side effect of morphine

    Time frame: 24 hours

    There were rate of sedation, respiratory failure, nause and vomiting, pruritus

  5. The satisfaction of participants: Likert

    Time frame: 24 hours

    It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

The Transversus Abdominis Plane Block

Acronym: TAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 16, 2018
Registry last updated
Aug 16, 2018

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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