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NCT04393207 · ClinicalTrials.gov registry record · Phase 4
TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery
A Phase 4 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 147
- Enrollment target
NCT04393207 is a Phase 4 study that was terminated before completion, run by Yale University. The registered enrollment target is 147 participants.
The verdict
NCT04393207, a Phase 4 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 147 participants
- Enrollment target
Study Summary
The TAP block offers analgesia by blocking the sensory nerves of the anterior abdominal wall. The procedure is performed under ultrasound guidance, after identification of the external oblique, internal oblique and transverse abdominis muscle. Medication is injected in the neurofascial plane between the internal oblique and the tranversus abdominis muscle. Previous studies have demonstrated limited (\<24 hour) effect of the block when compared to the use of intrathecal morphine (considered to be the "gold standard" for postoperative analgesia). In a study by McMarrow et al., post-caesarian pain control combinations including TAP blocks with local anesthetic (Bupivacaine) or saline after a spinal anesthetic with or without intrathecal morphine were compared. At 6 hours the Morphine consumption was slightly reduced in the patients that received both intrathecal morphine and TAP blocks with LA when compared to patients that received spinal saline and TAP with saline. At 24 hours the TAP block conferred no benefit in terms of opioid consumption. Similarly, the study by Lee et al. demonstrated better pain scores for the first 2 hours in patients receiving both intrathecal morphine and a TAP block with ropivacaine. At 24 hours there was no difference in the pain scores for patients that received both intrathecal morphine and TAP blocks. On the contrary, a more recent study utilizing liposomal bupivacaine has been utilized for TAP blocks for post cesarean delivery analgesia, demonstrating opioid reductions for up to 72 hours. Liposomal bupivacaine is a novel, multivesicular formulation designed for rapid absorption, prolonged release of bupivacaine, and analgesia following a single intra-operative administration into the surgical wound or for TAP blocks. Current anesthesia practices encourage the use of multimodal analgesia that aim at enhanced recovery after surgery (ERAS). The ERAS model aims to decrease immobility, pain and post-operative ileus. Pain and immobility
Interventions
- DRUG Liposomal bupivacaine (LB)
- DRUG Dexamethasone and methylprednisolone (CG)
- DRUG Control group (Bupivacaine)- (BPG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2023-11-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04393207
The ClinicalTrials.gov registry entry for NCT04393207 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Liposomal bupivacaine (LB) is the first listed.
NCT04393207 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04393207 about?
NCT04393207 is a clinical study titled "TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery". The TAP block offers analgesia by blocking the sensory nerves of the anterior abdominal wall. The procedure is performed under ultrasound guidance, after identification of the external oblique, internal oblique and transverse abdominis muscle. Medication is injected in the neurofascial plane between...
What is the current status of trial NCT04393207?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 147 participants. The study started on 2022-02-01. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT04393207?
The interventions under investigation include: Liposomal bupivacaine (LB) (DRUG), Dexamethasone and methylprednisolone (CG) (DRUG), Control group (Bupivacaine)- (BPG) (DRUG).
Who is sponsoring clinical trial NCT04393207?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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