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

Not Applicable

Active, not recruiting

• Conditions: Shoulder Injury; Pain
• Interventions: Procedure: Preemptive Interscalene Block - Single Shot; Procedure: Postoperative Interscalene Block - Catheter; Procedure: Postoperative Interscalene Block- Single Shot; Procedure: Preemptive Interscalene Block - Catheter

• Registration Number: NCT02666118
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preemptive Interscalene Block - Single Shot	Preemptive Interscalene Block - Single Shot	-
Postoperative Interscalene Block - Catheter	Postoperative Interscalene Block - Catheter	-
Postoperative Interscalene Block - Single Shot	Postoperative Interscalene Block- Single Shot	-
Preemptive Interscalene Block - Catheter	Preemptive Interscalene Block - Catheter	-

Primary Outcome Measures

Name	Time	Method
Pain Efficacy of Nerve Blockades	60 minutes	The primary outcome will be the worst pain score observed in the PACU using 0 (no pain) to 10 (worst pain) verbal Numerical Rating Scale (NRS) for pain by the study staff during the first post-operative hour.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States