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

April 1, 2024 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preemptive Interscalene Block - Single Shot
Procedure: Preemptive Interscalene Block - Single Shot
Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
Active Comparator: Postoperative Interscalene Block - Single Shot
Procedure: Postoperative Interscalene Block- Single Shot
Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
Active Comparator: Preemptive Interscalene Block - Catheter
Procedure: Preemptive Interscalene Block - Catheter
Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the induction of anesthesia, but prior to the start of surgery. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.
Active Comparator: Postoperative Interscalene Block - Catheter
Procedure: Postoperative Interscalene Block - Catheter
Interscalene brachial plexus blockade will be performed by the anesthesia team under ultrasound-guidance utilizing 1 ml/kg (to a maximum volume of 20 mls) of 0.2% ropivacaine without epinephrine. A continuous peripheral nerve catheter will then be placed under ultrasound-guidance for continuous infusion postoperatively. Regional anesthesia will be performed following the completion of surgery with the patient still under general anesthesia. Anesthesia team members determined to be proficient in regional blockade, having performed a minimum of ten successful interscalene brachial plexus blocks previously, will be performing the regional blockade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Efficacy of Nerve Blockades
Time Frame: 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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Marc Mecoli, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimated)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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