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NCT03577912 · ClinicalTrials.gov registry record · NA

Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: Surgeon vs Anesthesia - Ultrasound Guidance

A NA study of Post Operative Analgesia and Non-inferiority Trial, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT03577912: Completed NA study of Post Operative Analgesia and Non-inferiority Trial, sponsored by Beth Israel Deaconess Medical Center.

NCT03577912 is a NA study of Post Operative Analgesia and Non-inferiority Trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 60 participants, below the 118-participant average among 5 other Post Operative Analgesia trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03577912, a NA study of Post Operative Analgesia and Non-inferiority Trial, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.There are many methods to administer local anesthetic into the transversus abdominus plane to provide post-operative analgesia. The more prevalent method is for an anesthesia provider to inject local anesthetic into the plane using ultrasound guidance, before surgery or after the conclusion of surgery. Alternatively, a surgeon can administer the local anesthetic during the operation without additional time or expense using direct laparoscopic visualization. We propose to compare the two methods for non-inferiority, in the context of an established enhanced recovery after surgery (ERAS) program. Non-inferiority being established by no demonstrable difference in post-operative narcotic requirements and equivalent average pain scores.

Primary Outcome

overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery

Interventions

  • PROCEDURE TAP block administered by Surgery
  • PROCEDURE TAP block administered by Anesthesia

Study Locations (1)

Massachusetts

  • Beth Israel Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2015-08-17
Est. Completion 2018-07-31
Phase NA

What the finished NCT03577912 record still lists

NCT03577912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 118-participant average among 5 other Post Operative Analgesia trials with a reported enrollment target (49% lower).

The record links to 2 conditions, with Post Operative Analgesia appearing as the primary indexed condition, and to 2 interventions - of which TAP block administered by Surgery is the first listed.

NCT03577912 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03577912 about?

NCT03577912 is a clinical study titled "Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: Surgeon vs Anesthesia - Ultrasound Guidance". The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.T...

What is the current status of trial NCT03577912?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2015-08-17. Estimated completion is 2018-07-31.

What conditions does trial NCT03577912 study?

This clinical trial studies the following conditions: Post Operative Analgesia, Non-inferiority Trial.

What interventions are being tested in trial NCT03577912?

The interventions under investigation include: TAP block administered by Surgery (PROCEDURE), TAP block administered by Anesthesia (PROCEDURE).

Who is sponsoring clinical trial NCT03577912?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03577912 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03577912, the US trial registry maintained by the National Library of Medicine. NCT03577912 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.