Postoperative Pain
Conditions
Keywords
Ropivacaine, C-Section Analgesia, Tap Block
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.
Interventions
DRUGRopivacaine
Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Sponsors
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Pregnant patients undergoing elective c-section
Exclusion criteria
* Allergy to local anesthetics * Contraindication to tap blocks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 16 |
| Group 3 - No Tap Block Patients will not receive a TAP BLOCK | 18 |
| Total | 51 |
Baseline characteristics
| Characteristic | Group 1 - 0.5% Ropivacaine | Group 2 - 0.25% Ropivacaine | Group 3 - No Tap Block | Total |
|---|---|---|---|---|
| Age, Continuous | 32.65 years STANDARD_DEVIATION 6.3 | 29.17 years STANDARD_DEVIATION 4.29 | 31.0 years STANDARD_DEVIATION 4.72 | 30.94 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment United States | 17 participants | 16 participants | 18 participants | 51 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 18 Participants | 51 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 0 / 18 |
Outcome results
Primary
POSTOPERATIVE PAIN
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.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - 0.5% Ropivacaine | POSTOPERATIVE PAIN | 2.35 score on a scale | Standard Deviation 3.08 |
| Group 2 - 0.25% Ropivacaine | POSTOPERATIVE PAIN | 1.94 score on a scale | Standard Deviation 2.77 |
| Group 3 - No Tap Block | POSTOPERATIVE PAIN | 0.56 score on a scale | Standard Deviation 0.922 |