Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia

Not Applicable

Terminated

• Conditions: Postoperative Pain
• Interventions: Drug: Ropivacaine

• Registration Number: NCT02893423
• Lead Sponsor: Maimonides Medical Center

Brief Summary

With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section).

Detailed Description

With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section). The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. The investigators will inject the local anesthetic ropivacaine into this space to freeze these nerves and prevent pain following c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%, 0%) to determine the lowest dose that controls pain with the fewest side effects. Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3) ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain with cough will be collected along with the time to first postoperative analgesic request, patient satisfaction scores, and patient demographics. The analgesic regimen will be considered effective if it provides lower average visual analog scores for pain with movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer postoperative analgesic requests, and fewer side effects.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2016-06-26
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2022-05
• Results First Submitted: 2022-05-16
• Results First Submitted QC: 2022-08-27
• Last Update Submitted: 2022-08-27
• Results First Posted: 2022-09-21
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• Pregnant patients undergoing elective c-section

Exclusion criteria:

• Allergy to local anesthetics
• Contraindication to tap blocks

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - 0.25% Ropivacaine	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
Group 1 - 0.5% Ropivacaine	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

Primary Outcome Measures

Name	Time	Method
POSTOPERATIVE PAIN	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.

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States