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NCT02571439 · ClinicalTrials.gov registry record · Phase 4
Comparative Study of Two Different Techniques to Perform TAP-blocks
A Phase 4 study of Postoperative Pain, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT02571439: Completed Phase 4 study of Postoperative Pain, sponsored by Maimonides Medical Center.
NCT02571439 is a Phase 4 study of Postoperative Pain that has completed, run by Maimonides Medical Center. The registered enrollment target is 41 participants, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02571439, a Phase 4 study of Postoperative Pain, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will block these nerves and prevent pain following c-section. The investigators will compare two different approaches to injecting the local anesthetic in this space. Conventionally, the block is done after surgery is completed and the abdomen is closed. The anesthesiologist introduces a needle through the abdominal wall skin under ultrasound guidance to reach the TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the abdominal (belly) wall and is closer to the inside of the abdomen than to the outside (skin), injecting from the inner aspect of the abdominal wall during the surgery is easier and quicker to perform than the conventional block and does not require ultrasound guidance as there is no risk of injury to abdominal organs like the liver. With this research the investigators attempt to prove that surgically administered TAP blocks take 25% less time to perform compared to the conventionally administered TAP block for post cesarean section pain relief. Surgical TAP blocks are also more cost-effective as in addition to reduced OR time, they are safer and do not require skilled operator and specialized equipment. Secondary outcomes will include total time spent in the Operating room, presence and severity of postoperative pain, time to first request for pain medication, total postoperative narcotic consumption in 48 hours after surgery and side effects.
Primary Outcome
Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.
Conditions Studied
Interventions
- PROCEDURE Surgical TAP block
- PROCEDURE Conventional TAP block
- DRUG 0.5% ropivacaine
Study Locations (1)
New York
- Maimonides Medical Center - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT02571439 record still lists
NCT02571439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 3 interventions - of which Surgical TAP block is the first listed.
NCT02571439 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02571439 about?
NCT02571439 is a clinical study titled "Comparative Study of Two Different Techniques to Perform TAP-blocks". The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will block these nerves and prevent pain following c-section. The investigators will compare two different approaches to inje...
What is the current status of trial NCT02571439?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2014-10. Estimated completion is 2015-08.
What conditions does trial NCT02571439 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT02571439?
The interventions under investigation include: Surgical TAP block (PROCEDURE), Conventional TAP block (PROCEDURE), 0.5% ropivacaine (DRUG).
Who is sponsoring clinical trial NCT02571439?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02571439 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02571439's enrollment target sits among peer trials
41 108th of 120 higher than 13 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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