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

Obstetric Pain Clinical Trial

— TAP  

Official title:

The Transversus Abdominis Plane Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634111
• Other study ID #: 11-2017/CN-HÐÐÐ
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: August 2018
• Source: Gia Dinh People Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2018
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

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

Drug:
• Morphine
Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 gi?.
• Ropivacaine
Ropivacaine 0.25% 20 ml each side

Locations

Country	Name	City	State
Vietnam	THANG Nguyen Trong	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption during 24 hours	Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).	24 hours
Secondary	The time required the first of dose of morphine (hours)	The time was from the end of surgery to the participants required the first of dose of morphine with PCA.	24 hours
Secondary	Pain score: VAS	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	24 hours
Secondary	The rate of complications of TAP block	There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall	24 hours
Secondary	The rate of side effect of morphine	There were rate of sedation, respiratory failure, nause and vomiting, pruritus	24 hours
Secondary	The satisfaction of participants: Likert	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	24 hours