Phase 4
N=120
Transverse Abdominis Plane (TAP) Block After Cesarean Delivery
Postoperative Pain · Pregnancy · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01170702 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Morphine Equivalents 0-24 Hours (Mgs) — 54; 38; 32; 45 Morphine equivalents (mg) — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0.9% Normal Saline (Drug); 0.2% Ropivacaine (Drug); 0.5% Ropivacaine (Drug); 0.75% Ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Equivalents 0-24 Hours (Mgs) |
54; 38; 32; 45 | .05 |
| SECONDARY Morphine Equivalents 24-72 Hours (Mgs) |
67; 60; 67; 67 | — |
| SECONDARY Morphine Equivalents Total (Mgs) |
120; 96; 98; 112 | — |
| SECONDARY Time to First PCA Request |
90; 118; 126; 83 | — |
| SECONDARY Pain Scores at Rest |
3; 3; 2; 2; 3; 1 | — |
| SECONDARY Pain Scores With Movement |
5; 3.5; 3.5; 4; 4; 2 | — |
| SECONDARY Pain Burden at Rest |
129; 79; 79; 151 | — |
| SECONDARY Pain Burden With Movement |
265; 202; 233; 327 | — |
Summary
Since there have been no published dose-response studies investigating the effective analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia, the investigators propose a study primarily examining the effect on 24 hour post-Cesarean delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine, or 0.75% ropivacaine for TAP blocks.
Eligibility Criteria
Inclusion Criteria
- ASA II-III patient
- > 18 years of age who is pregnant
- presenting for a cesarean delivery via Pfannenstiel incision who is eligible to receive a spinal anesthetic with 0.75% bupivacaine and fentanyl and whose is not eligible to receive intrathecal morphine due to a BMI >40 kg/m2.
Exclusion Criteria
- < 18 years of age
- contraindication to placement of a spinal anesthetic
- contraindication to use of non-steroidal anti-inflammatory drugs (NSAIDs)
- patients receiving medical therapies considered to result in tolerance to opioids
- patients with a history of established chronic pain, (e.g. chronic low back pain, fibromyalgia or headaches), defined as requiring regular medical follow-up with pain specialists, as well as recent use (within the year preceding pregnancy) of opioid analgesics as an outpatient
- patients with a history of diabetes mellitus
- patients undergoing a vertical midline skin incision
- patients who are undergoing a cesarean delivery after a failed vaginal trial of labor
- patients who had a prior epidural placed for labor analgesia during the same hospital encounter.
Data sourced from ClinicalTrials.gov (NCT01170702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.