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

• ClinicalTrials.gov Identifier: NCT03634111
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Last Update Posted: August 16, 2018
• Sponsor: Gia Dinh People Hospital
• Information provided by (Responsible Party): Gia Dinh People Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obstetric Pain	Procedure: TAP block; Drug: Morphine; Drug: Ropivacaine	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Transversus abdominis plane block under the ultrasound guidance
• Masking: None (Open Label)
• Masking Description: Participants were cesarean section with general anesthesia
• Primary Purpose: Other
• Official Title: The Transversus Abdominis Plane Block
• Actual Study Start Date: July 10, 2017
• Actual Primary Completion Date: July 15, 2017
• Actual Study Completion Date: March 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: T group; The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.	Procedure: TAP block; TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.; Other Name: Transversus abdominis plane block; Drug: Morphine; Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.; Other Name: Opioids; Drug: Ropivacaine; Ropivacaine 0.25% 20 ml each side; Other Name: Anaropin
Placebo Comparator: C group; The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia	Drug: Morphine; Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.; Other Name: Opioids; Drug: Ropivacaine; Ropivacaine 0.25% 20 ml each side; Other Name: Anaropin

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Vietnam

THANG Nguyen Trong

Ho Chi Minh, Vietnam, 700000

Sponsors and Collaborators

Gia Dinh People Hospital

Investigators

• Principal Investigator: THANG T Nguyen, Mr; Gia Dinh People Hospital

More Information

• Responsible Party: Gia Dinh People Hospital
• ClinicalTrials.gov Identifier: NCT03634111
• Other Study ID Numbers: 11-2017/CN-HĐĐĐ
• First Posted: August 16, 2018
• Last Update Posted: August 16, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gia Dinh People Hospital:

transversus abdominis plane block (TAP block); postoperative analgesia; cesarean section

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations; Morphine; Ropivacaine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics