Efficacy of Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Intervention

Status:Enrolling by invitation
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Age Range:10 - 21
Start Date:February 2013
End Date:January 2018

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Randomized Prospective Comparison of Analgesic Efficacy of Peripheral Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Shoulder Repair

Nerve blocks, or pain medication injected next to the nerve while patients are asleep, are
commonly used for pain management after shoulder surgery and are considered highly effective
in decreasing post-operative pain. There are several different ways to give a nerve block.
All are effective and safe. The purpose of this research is to determine if one of the
available ways to give a nerve block is more effective than the others.

Interscalene brachial plexus blockade is commonly performed to provide relief of
postoperative pain following surgical shoulder repair. This has proven to be a reliable
means of reducing the required doses of intraoperative and postoperative opiates and
effectively delaying postoperative pain, as well as hastening patient discharge and
increasing patient satisfaction. Neural blockade has traditionally been performed prior to
surgery with the hope that preemptive analgesia will most effectively abate postoperative
pain. Recently, however, it has been argued that sensitization to pain can be attributed to
many factors, not solely the nociceptive battery associated with incision and subsequent
intraoperative events.[1] The duration of action and effectiveness of the treatment modality
thus appear play a more important role than the actual timing of the treatment delivered.[2]
The safety and efficacy of performing interscalene brachial plexus blockade under general
anesthesia has recently been reported as being not only safe, but perhaps more effective
than when performed in an awake patient.[3] We propose a randomized prospective evaluation
of the analgesic efficacy comparing interscalene brachial plexus blockade performed prior to
surgery with interscalene brachial plexus blockade performed following the completion of of
surgery in healthy ASA I and II adolescent patients undergoing unilateral shoulder
reconstruction on an outpatient basis.

Inclusion Criteria:

- The subject is male or female;

- The subject is of any racial and ethnic groups;

- The subject is age 10 years to 21 years (inclusive);

- The subject is scheduled for the following

- Unilateral shoulder repair under general anesthesia on an out- patient basis, and not
being performed in conjunction with any other surgical procedures;

- Agreement of the surgeon for subject participation in study.

- The subject or legally authorized representative has consented to an intra- scalene
block for the procedure and the consent for the block has been obtained by an
clinician (MD, DO, CRNA or APN) authorized to obtain consent who is independent of
the study team

- The subject is American Society of Anesthesiologists (ASA) patient classification

- The subject's legally authorized representative has given written informed consent to
participate in the study and when appropriate, the subject has given assent or
consent to participate.

Exclusion Criteria:

- Additional surgical procedures are being performed concurrently;

- The subject is ASA classification > II;

- The subject has pre-existing allergies to local anesthetics;

- The subject receives sedation preoperatively;

- The subject has an imminent life threatening condition that impacts the ability to
obtain informed consent;

- The subject has any other condition, which in the opinion of the principal
investigator, would not be suitable for participation in the study, including but not
limited preexisting neuropathy.
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Cincinnati, OH
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