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

Primary Purpose

Pain, Shoulder Injury

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Preemptive Interscalene Block - Single Shot

Postoperative Interscalene Block- Single Shot

Preemptive Interscalene Block - Catheter

Postoperative Interscalene Block - Catheter

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, pain management, shoulder repair, nerve blockade, regional anesthesia, pediatrics

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Preemptive Interscalene Block - Single Shot

Postoperative Interscalene Block - Single Shot

Preemptive Interscalene Block - Catheter

Postoperative Interscalene Block - Catheter

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02666118

First Posted

January 26, 2016

Last Updated

August 30, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT02666118

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 2013 (undefined)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Shoulder Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preemptive Interscalene Block - Single Shot

Arm Type

Active Comparator

Arm Title

Postoperative Interscalene Block - Single Shot

Arm Type

Active Comparator

Arm Title

Preemptive Interscalene Block - Catheter

Arm Type

Active Comparator

Arm Title

Postoperative Interscalene Block - Catheter

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Preemptive Interscalene Block - Single Shot

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Postoperative Interscalene Block- Single Shot

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Preemptive Interscalene Block - Catheter

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Postoperative Interscalene Block - Catheter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Efficacy of Nerve Blockades

Description

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamie Furstein, CRNA

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21965352

Citation

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. Erratum In: Anesth Analg. 2011 Dec;113(6):1475.

Results Reference

background

PubMed Identifier

21455081

Citation

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.

Results Reference

background

PubMed Identifier

20708419

Citation

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.

Results Reference

background

PubMed Identifier

20048655

Citation

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. Erratum In: Reg Anesth Pain Med. 2010 Mar-Apr;35(2):226. Fredrickson, Michel J [corrected to Fredrickson, Michael J].

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

14673442

Citation

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.

Results Reference

background

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

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