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

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Cincinnati Children's Hospital Medical Center

Status

Active, not recruiting

Conditions

Shoulder Injury
Pain

Treatments

Procedure: Preemptive Interscalene Block - Single Shot
Procedure: Postoperative Interscalene Block- Single Shot
Procedure: Postoperative Interscalene Block - Catheter
Procedure: Preemptive Interscalene Block - Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02666118
2012-0486

Details and patient eligibility

About

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.

Full description

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. 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. 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. 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.

Enrollment

79 patients

Sex

All

Ages

10 to 21 years old

Volunteers

No Healthy Volunteers

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 I-II;
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

79 participants in 4 patient groups

Preemptive Interscalene Block - Single Shot
Active Comparator group
Treatment:
Procedure: Preemptive Interscalene Block - Single Shot
Postoperative Interscalene Block - Single Shot
Active Comparator group
Treatment:
Procedure: Postoperative Interscalene Block- Single Shot
Preemptive Interscalene Block - Catheter
Active Comparator group
Treatment:
Procedure: Preemptive Interscalene Block - Catheter
Postoperative Interscalene Block - Catheter
Active Comparator group
Treatment:
Procedure: Postoperative Interscalene Block - Catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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