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

NCT02666118 | Active Not Recruiting

• 1 other identifier: 2012-0486
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Shoulder Injury

Keywords

pain; pain management; shoulder repair; nerve blockade; regional anesthesia; pediatrics

Outcome Measures

Primary Outcomes (1)

• Pain Efficacy of Nerve Blockades

  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

Study Arms (4)

Preemptive Interscalene Block - Single Shot

ACTIVE COMPARATOR

Procedure: Preemptive Interscalene Block - Single Shot

Postoperative Interscalene Block - Single Shot

ACTIVE COMPARATOR

Procedure: Postoperative Interscalene Block- Single Shot

Preemptive Interscalene Block - Catheter

ACTIVE COMPARATOR

Procedure: Preemptive Interscalene Block - Catheter

Postoperative Interscalene Block - Catheter

ACTIVE COMPARATOR

Procedure: Postoperative Interscalene Block - Catheter

Interventions

Preemptive Interscalene Block - Single Shot PROCEDURE

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.

Preemptive Interscalene Block - Single Shot

Postoperative Interscalene Block- Single Shot PROCEDURE

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.

Postoperative Interscalene Block - Single Shot

Preemptive Interscalene Block - Catheter PROCEDURE

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.

Preemptive Interscalene Block - Catheter

Postoperative Interscalene Block - Catheter PROCEDURE

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.

Postoperative Interscalene Block - Catheter

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (6)

• Katz J, Clarke H, Seltzer Z. Review article: Preventive analgesia: quo vadimus? Anesth Analg. 2011 Nov;113(5):1242-53. doi: 10.1213/ANE.0b013e31822c9a59. Epub 2011 Sep 30.

  PMID: 21965352 BACKGROUND

• Lavand'homme P. From preemptive to preventive analgesia: time to reconsider the role of perioperative peripheral nerve blocks? Reg Anesth Pain Med. 2011 Jan-Feb;36(1):4-6. doi: 10.1097/AAP.0b013e31820305b8. No abstract available.

  PMID: 21455081 BACKGROUND

• Misamore G, Webb B, McMurray S, Sallay P. A prospective analysis of interscalene brachial plexus blocks performed under general anesthesia. J Shoulder Elbow Surg. 2011 Mar;20(2):308-14. doi: 10.1016/j.jse.2010.04.043. Epub 2010 Aug 13.

  PMID: 20708419 BACKGROUND

• Fredrickson MJ, Ball CM, Dalgleish AJ. Analgesic effectiveness of a continuous versus single-injection interscalene block for minor arthroscopic shoulder surgery. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):28-33. doi: 10.1097/AAP.0b013e3181c771bd.

  PMID: 20048655 BACKGROUND

• Hadzic A, New York School of Regional Anesthesia: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007

  BACKGROUND

• Angelo RL. Controversies in arthroscopic shoulder surgery: arthroscopic versus open bankart repair, thermal treatment of capsular tissue, acromioplasties--are they necessary? Arthroscopy. 2003 Dec;19 Suppl 1:224-8. doi: 10.1016/j.arthro.2003.10.005. No abstract available.

  PMID: 14673442 BACKGROUND

MeSH Terms

Conditions

Pain; Shoulder Injuries; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Marc Mecoli, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 28, 2016
• Study Start: February 1, 2013
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)