PainNCT02666118
Efficacy of Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Intervention
A study testing Preemptive Interscalene Block - Single Shot, Postoperative Interscalene Block- Single Shot and Preemptive Interscalene Block - Catheter in people with Pain and Shoulder Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pain, Shoulder Injury
- What is being tested?
- Preemptive Interscalene Block - Single Shot, Postoperative Interscalene Block- Single Shot and Preemptive Interscalene Block - Catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Shoulder Injury
- Being tested
- Preemptive Interscalene Block - Single Shot, Postoperative Interscalene Block- Single Shot, Preemptive Interscalene Block - Catheter, Postoperative Interscalene Block - Catheter
- Keywords
- pain, pain management, shoulder repair, nerve blockade, regional anesthesia, pediatrics
- Medical subject headings
- Pain, Shoulder Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive Interscalene Block - Single ShotProcedure or surgery
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.
Postoperative Interscalene Block- Single ShotProcedure or surgery
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.
Preemptive Interscalene Block - CatheterProcedure or surgery
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.
Postoperative Interscalene Block - CatheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Preemptive Interscalene Block - Single Shot | Active comparator | Not described Receives: Procedure: Preemptive Interscalene Block - Single Shot |
| Postoperative Interscalene Block - Single Shot | Active comparator | Not described Receives: Procedure: Postoperative Interscalene Block- Single Shot |
| Preemptive Interscalene Block - Catheter | Active comparator | Not described Receives: Procedure: Preemptive Interscalene Block - Catheter |
| Postoperative Interscalene Block - Catheter | Active comparator | Not described Receives: Procedure: Postoperative Interscalene Block - Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2013
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Mecoli, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666118
- Sponsor's protocol ID
- 2012-0486
- Status last verified
- Apr 2024
- First submitted
- 26 Jan 2016
- Last updated
- 2 Apr 2024
- Results posted
- No
Publications
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.
PubMed 21965352Lavand'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.
PubMed 21455081Misamore 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.
PubMed 20708419Fredrickson 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.
PubMed 20048655Hadzic A, New York School of Regional Anesthesia: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007
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.
PubMed 14673442
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Comparison of Analgesic Efficacy of Peripheral Nerve Blockade Performed Prior to Surgical Intervention Versus Following Surgical Shoulder Repair
- ClinicalTrials.gov ID
- NCT02666118
- Acronym / sponsor ID
- 2012-0486
- Conditions
- Pain, Shoulder Injury
- Keywords
- pain, pain management, shoulder repair, nerve blockade, regional anesthesia, pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemptive Interscalene Block - Single ShotInterscalene 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. | Procedure or surgery | Preemptive Interscalene Block - Single Shot |
| Postoperative Interscalene Block- Single ShotInterscalene 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. | Procedure or surgery | Postoperative Interscalene Block - Single Shot |
| Preemptive Interscalene Block - CatheterInterscalene 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. | Procedure or surgery | Preemptive Interscalene Block - Catheter |
| Postoperative Interscalene Block - CatheterInterscalene 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. | Procedure or surgery | Postoperative Interscalene Block - Catheter |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 21965352Katz 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.
- Background: PubMed 21455081Lavand'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.
- Background: PubMed 20708419Misamore 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.
- Background: PubMed 20048655Fredrickson 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.
- BackgroundHadzic A, New York School of Regional Anesthesia: Textbook of regional anesthesia and acute pain management. New York: McGraw-Hill, Medical Pub. Division; 2007
- Background: PubMed 14673442Angelo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Mecoli, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preemptive Interscalene Block - Single Shot, Postoperative Interscalene Block- Single Shot and Preemptive Interscalene Block - Catheter in people with Pain and Shoulder Injury, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Efficacy of Nerve Blockades (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666118, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.