Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia (TAPROPI)

Maimonides Medical Center

Status: Terminated

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02893423

Study # 13/01/VA01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 51 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant patients undergoing elective c-section

Exclusion criteria

• Allergy to local anesthetics
• Contraindication to tap blocks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

51 participants in 3 patient groups

Group 1 - 0.5% Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Group 2 - 0.25% Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Group 3 - No Tap Block

No Intervention group

Description:

Patients will not receive a TAP BLOCK