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Trial Outcomes & Findings for Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia (NCT NCT02893423)

NCT ID: NCT02893423

Last Updated: 2022-09-21

Results Overview

Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

48 hours

Results posted on

2022-09-21

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1 - 0.5% Ropivacaine
Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 2 - 0.25% Ropivacaine
Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 3 - No Tap Block
Patients will not receive a TAP BLOCK
Overall Study
STARTED
17
16
18
Overall Study
COMPLETED
17
16
18
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1 - 0.5% Ropivacaine
n=17 Participants
Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 2 - 0.25% Ropivacaine
n=16 Participants
Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 3 - No Tap Block
n=18 Participants
Patients will not receive a TAP BLOCK
Total
n=51 Participants
Total of all reporting groups
Age, Continuous
32.65 years
STANDARD_DEVIATION 6.30 • n=5 Participants
29.17 years
STANDARD_DEVIATION 4.29 • n=7 Participants
31.0 years
STANDARD_DEVIATION 4.72 • n=5 Participants
30.94 years
STANDARD_DEVIATION 5.10 • n=4 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
16 Participants
n=7 Participants
18 Participants
n=5 Participants
51 Participants
n=4 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
17 participants
n=5 Participants
16 participants
n=7 Participants
18 participants
n=5 Participants
51 participants
n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain.

Outcome measures

Outcome measures
Measure
Group 1 - 0.5% Ropivacaine
n=17 Participants
Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 2 - 0.25% Ropivacaine
n=16 Participants
Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin Ropivacaine: Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Group 3 - No Tap Block
n=18 Participants
Patients will not receive a TAP BLOCK
POSTOPERATIVE PAIN
2.35 score on a scale
Standard Deviation 3.08
1.94 score on a scale
Standard Deviation 2.77
0.56 score on a scale
Standard Deviation .922

Adverse Events

Group 1 - 0.5% Ropivacaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2 - 0.25% Ropivacaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 3 - No Tap Block

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kalpana Tyagaraj

Maimonides Medical Center

Phone: 718-283-1753

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place