Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia

NCT ID: NCT02893423

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2016-09-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine

Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients

Intervention Type: DRUG

Other Intervention Names

Naropin

Eligibility Criteria

Inclusion Criteria

• Pregnant patients undergoing elective c-section

Exclusion Criteria

• Allergy to local anesthetics
• Contraindication to tap blocks

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

kalpana tyagaraj

Residency Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KALPANA TYAGARAJ, MD

Role: PRINCIPAL_INVESTIGATOR

MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

Study # 13/01/VA01

Identifier Type: -

Identifier Source: org_study_id