Arthroscopic Shoulder SurgeryNCT03691922
Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Arthroscopic Shoulder Surgery
A study testing Erector Spinae Plane (ESP) Block and Periarticular Infiltration (PAI) in people with Arthroscopic Shoulder Surgery, run by McMaster University at 1 site in Canada.
Trial summary
Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies, but it is often associated with moderate to severe postoperative pain that may interfere with patients' well-being and course of recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- Erector Spinae Plane (ESP) Block and Periarticular Infiltration (PAI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2019to 1 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective arthroscopic shoulder joint surgeries admitted for day surgical procedure
- an ability to provide informed consent
Who cannot join
- not willing
- contraindications to spinal injections as per the American Society of Regional Anesthesia and Pain (ASRA) guidelines
- known allergy to LA
- allergy to all opioid medications
- diagnostic shoulder arthroscopic procedures
- inability to understand or comprehend in English language
- history of daily opioid medication use for the last one month
- patients with planned overnight hospital stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery
Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies, but it is often associated with moderate to severe postoperative pain that may interfere with patients' well-being and course of recovery. By using an effective analgesic technique with few side effects, a patient may experience less pain after surgery, have a shortened hospital stay, and endure less nausea, vomiting, or excessive drowsiness that are associated with the use of opioids to manage postoperative pain. Periarticular infiltration (PAI) with local anesthetic (LA) has been used for shoulder surgery pain management, but the more effective interscalene nerve block (ISNB) is the current gold standard analgesic modality despite risk of significant side effects including diaphragm paralysis and rebound pain. In this study, the investigators want to look at the effectiveness and safety profile of a novel technique for pain management after shoulder surgery that has the potential to provide successful pain relief with minimal risk of side effects. Half of the patients will be randomly selected to receive the novel nerve block called the Erector Spinae Plane (ESP) block while the other half will receive a more standard PAI of local anesthetic to numb the shoulder. Patients' pain intensity and opioid consumption in the post-anesthesia care unit (PACU) as well as during the first 24 hours after surgery will be evaluated. Any complications from the interventions will also be noted. The investigators predict that the ESP block will provide superior analgesia compared to PAI for these shoulder arthroscopy patients.
Read the detailed description
The use of opioids to manage immediate postoperative pain is frequently associated with nausea, vomiting, respiratory depression, hormonal effects and dysphoria. As such, achieving pain control while minimizing opioid use is critical, since more than 60% of unplanned prolonged hospitalizations and hospital readmissions are thought to be related to inadequate pain control or to side effects of opioids. A number of techniques have been used to achieve good pain control after arthroscopic shoulder surgery, including periarticular infiltration (PAI) with local anesthetic (LA) and regional anesthetic nerve blocks. Although PAI in the shoulder has been shown to decrease shoulder pain and opioid consumption, it is not as effective as regional blocks such as the interscalene nerve block (ISNB), which is the current gold standard. Nevertheless, the ISNB is potentially associated with significant side effects including persistent neurologic complications, rebound pain, phrenic nerve palsy, respiratory distress, cardiac arrest pneumothorax and central nerve toxicity. In view of this, investigating alternate regional blocks having the potential for good pain relief with minimal side effects is important. The Erector Spinae Plane (ESP) block can be considered as a modification of thoracic paravertebral block (PVB) that blocks thoracic spinal nerves using injections outside of the conventional paravertebral space. It is performed under ultrasound (US) by injecting local anesthetic deep to the erector spinae muscle at the interfascial space between either the erector spinae muscle and the rhomboid major muscle (higher up), or between the erector spinae muscle and the external intercostal muscles, at lower sites. Cadaveric studies of ultrasound-guided ESP blocks with methylene blue dye and subsequent dissection, as well an ESP block with a dye mixture and CT scanning demonstrated that when injecting deep into the erector spinae, the block likely affects the ventral and dorsal rami leading to the sensory blockade. The advantages include its simplicity and safety by limiting the risk of nerve damage and pneumothorax. Various case reports have demonstrated the ESP block to be successful for abdominal, breast and axillary, and other surgery types, and a recent case report described the successful management of chronic shoulder pain without motor blockade, with ESP performed at T3 level. The investigators conducted a systematic review via Pubmed to identify studies that have utilized ESP for post-surgical shoulder pain. Out of 77 reports, the investigators did not identify any comparative studies looking at the potential of ESP for shoulder surgery pain. The investigators also looked into ongoing and proposed trials of ESP by looking into clinicaltrials.gov. The investigators identified 21 studies including some randomized controlled trials (RCT) for thoracic surgery and general surgery population, but none for shoulder surgeries. Given the importance of providing adequate analgesia for arthroscopic shoulder surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, this trial will help establish the effectiveness of the ESP block in pain control after shoulder arthroscopy and define its safety profile. The results of this trial will allow the clinician to inform patients accurately regarding the benefits and risks of the block and thus guide the clinical practice of this block for shoulder arthroscopy. If proven to be effective, it may be used as an alternative to ISNB, especially in cases where ISNB is contraindicated.
- Conditions
- Arthroscopic Shoulder Surgery
- Being tested
- Erector Spinae Plane (ESP) Block, Periarticular Infiltration (PAI)
- Keywords
- Shoulder, Pain, Erector Spinae Plane block, Surgery, Arthroscopy, Periarticular infiltration, Post-Anesthesia Care Unit, Day Surgery Unit, Regional anesthesia, Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) BlockProcedure or surgery
Also called 0.25% bupivacaine with 5 mcg/mL of epinephrine & PAI with 30 mL of saline
- Preoperative US guided ESP blockade using 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine, injected in 5-mL aliquots through the needle (maximum of 3 mg/kg)
- PAI of 30 mL of saline at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle
Periarticular Infiltration (PAI)Procedure or surgery
Also called ESP block with 30 mL of saline & PAI with 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine
- Preoperative US guided ESP blockade using 30 mL of saline, injected in 5-mL aliquots through the needle
- PAI of 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Active comparator | Preoperative US guided active Erector Spinae Plane (ESP) block and a saline PAI Receives: Procedure: Erector Spinae Plane (ESP) Block |
| PAI with LA | Other | Preoperative US guided ESP blockade with saline and an active Periarticular Infiltration (PAI) Receives: Procedure: Periarticular Infiltration (PAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery room resting pain score
Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
Measured: At 30 minutes post-admission to recovery room
Secondary outcomes (10)
Day Surgery Unit resting pain score
Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
Measured: At 5 hours post-operatively
Pain scores with movement
Using the patient-reported numeric rating scale (0-10). (0 is no pain and 10 is worst pain imaginable). Participants will be asked to sit up from lying down position.
Measured: At 30 minutes post-admission to recovery room and 5 hours post-operatively
Opioid usage
All opioids administered in recovery room and day surgery unit will be converted into Morphine Equivalent Units per patient according to accepted standards.
Measured: At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe postoperative nausea-vomiting
Using a 0-3 scale (0 is none and 3 severe nausea-vomiting)
Measured: At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe itching
Using a 0-3 scale (0 is none and 3 severe itching)
Measured: At 2 hours post-operatively and 5 hours post-operatively
Incidence of ipsilateral diaphragmatic paralysis
Diagnosed based on the findings in an anterior posterior chest using ultrasound , with the criteria of "a right hemidiaphragm sitting >2 cm higher than its left counterpart or a left hemidiaphragm sitting equal or higher than the right hemidiaphragm".
Measured: 30 minutes post-admission to recovery room
Incidence of respiratory depression
Opioids discontinued by the Acute Pain Service or recovery room nursing due to concerns of respiratory depression by nursing staff.
Measured: At 2 hours post-operatively and 5 hours post-operatively
Incidence of local anesthetic toxicity
Based on clinical symptoms and signs of local anesthetic toxicity as diagnosed by the attending physician.
Measured: At 2 hours post-operatively and 5 hours post-operatively
Sensory blockade
Seven sensory dermatomes corresponding to shoulder and upper arm and their blockade to cold sensation will be noted. The extent of blockade between the two groups will be compared by their median and range.
Measured: At 30 minutes post-admission to recovery room
Patient Satisfaction with Postoperative Analgesia
Using a 7-item Likert scale (1 is extremely satisfied and 7 is extremely dissatisfied)
Measured: At 5 hours post-operatively and 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start6 Jul 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harsha Shanthanna, MD, Principal investigator, St. Joseph's Healthcare Hamilton/McMaster UniversityBashar Alolabi, MD, Principal investigator, St. Joseph's Healthcare HamiltonMark Czuczman, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691922
- Sponsor's protocol ID
- 4668
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2018
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fontana C, Di Donato A, Di Giacomo G, Costantini A, De Vita A, Lancia F, Caricati A. Postoperative analgesia for arthroscopic shoulder surgery: a prospective randomized controlled study of intraarticular, subacromial injection, interscalenic brachial plexus block and intraarticular plus subacromial injection efficacy. Eur J Anaesthesiol. 2009 Aug;26(8):689-93. doi: 10.1097/eja.0b013e32832d673e.
PubMed 19593887Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010 Sep-Oct;13(5):401-35.
PubMed 20859312Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.
PubMed 9322460Barber FA, Herbert MA. The effectiveness of an anesthetic continuous-infusion device on postoperative pain control. Arthroscopy. 2002 Jan;18(1):76-81. doi: 10.1053/jars.2002.25976.
PubMed 11774146Merivirta R, Kuusniemi KS, Aantaa R, Hurme SA, Aarimaa V, Leino KA. The analgesic effect of continuous subacromial bupivacaine infusion after arthroscopic shoulder surgery: a randomized controlled trial. Acta Anaesthesiol Scand. 2012 Feb;56(2):210-6. doi: 10.1111/j.1399-6576.2011.02606.x.
PubMed 22236345Harvey GP, Chelly JE, AlSamsam T, Coupe K. Patient-controlled ropivacaine analgesia after arthroscopic subacromial decompression. Arthroscopy. 2004 May;20(5):451-5. doi: 10.1016/j.arthro.2004.03.004.
PubMed 15122133Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
PubMed 27729319Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.
PubMed 27079219Shin SW, Byeon GJ, Yoon JU, Ok YM, Baek SH, Kim KH, Lee SJ. Effective analgesia with ultrasound-guided interscalene brachial plexus block for postoperative pain control after arthroscopic rotator cuff repair. J Anesth. 2014 Feb;28(1):64-9. doi: 10.1007/s00540-013-1681-x. Epub 2013 Aug 1.
PubMed 23903900Misamore 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 20708419Webb BG, Sallay PI, McMurray SD, Misamore GW. Comparison of Interscalene Brachial Plexus Block Performed With and Without Steroids. Orthopedics. 2016 Nov 1;39(6):e1100-e1103. doi: 10.3928/01477447-20160819-02. Epub 2016 Aug 30.
PubMed 27575034Candido KD, Sukhani R, Doty R Jr, Nader A, Kendall MC, Yaghmour E, Kataria TC, McCarthy R. Neurologic sequelae after interscalene brachial plexus block for shoulder/upper arm surgery: the association of patient, anesthetic, and surgical factors to the incidence and clinical course. Anesth Analg. 2005 May;100(5):1489-1495. doi: 10.1213/01.ANE.0000148696.11814.9F.
PubMed 15845712Nam YS, Jeong JJ, Han SH, Park SE, Lee SM, Kwon MJ, Ji JH, Kim KS. An anatomic and clinical study of the suprascapular and axillary nerve blocks for shoulder arthroscopy. J Shoulder Elbow Surg. 2011 Oct;20(7):1061-8. doi: 10.1016/j.jse.2011.04.022. Epub 2011 Aug 11.
PubMed 21839653Costache I, de Neumann L, Ramnanan CJ, Goodwin SL, Pawa A, Abdallah FW, McCartney CJL. The mid-point transverse process to pleura (MTP) block: a new end-point for thoracic paravertebral block. Anaesthesia. 2017 Oct;72(10):1230-1236. doi: 10.1111/anae.14004. Epub 2017 Aug 1.
PubMed 28762464Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03691922
- Acronym / sponsor ID
- 4668
- Conditions
- Arthroscopic Shoulder Surgery
- Keywords
- Shoulder, Pain, Erector Spinae Plane block, Surgery, Arthroscopy, Periarticular infiltration, Post-Anesthesia Care Unit, Day Surgery Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 2 Oct 2018 (actual)
- 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.
Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies, but it is often associated with moderate to severe postoperative pain that may interfere with patients' well-being and course of recovery. By using an effective analgesic technique with few side effects, a patient may experience less pain after surgery, have a shortened hospital stay, and endure less nausea, vomiting, or excessive drowsiness that are associated with the use of opioids to manage postoperative pain. Periarticular infiltration (PAI) with local anesthetic (LA) has been used for shoulder surgery pain management, but the more effective interscalene nerve block (ISNB) is the current gold standard analgesic modality despite risk of significant side effects including diaphragm paralysis and rebound pain. In this study, the investigators want to look at the effectiveness and safety profile of a novel technique for pain management after shoulder surgery that has the potential to provide successful pain relief with minimal risk of side effects. Half of the patients will be randomly selected to receive the novel nerve block called the Erector Spinae Plane (ESP) block while the other half will receive a more standard PAI of local anesthetic to numb the shoulder. Patients' pain intensity and opioid consumption in the post-anesthesia care unit (PACU) as well as during the first 24 hours after surgery will be evaluated. Any complications from the interventions will also be noted. The investigators predict that the ESP block will provide superior analgesia compared to PAI for these shoulder arthroscopy patients.
Detailed description
The use of opioids to manage immediate postoperative pain is frequently associated with nausea, vomiting, respiratory depression, hormonal effects and dysphoria. As such, achieving pain control while minimizing opioid use is critical, since more than 60% of unplanned prolonged hospitalizations and hospital readmissions are thought to be related to inadequate pain control or to side effects of opioids. A number of techniques have been used to achieve good pain control after arthroscopic shoulder surgery, including periarticular infiltration (PAI) with local anesthetic (LA) and regional anesthetic nerve blocks. Although PAI in the shoulder has been shown to decrease shoulder pain and opioid consumption, it is not as effective as regional blocks such as the interscalene nerve block (ISNB), which is the current gold standard. Nevertheless, the ISNB is potentially associated with significant side effects including persistent neurologic complications, rebound pain, phrenic nerve palsy, respiratory distress, cardiac arrest pneumothorax and central nerve toxicity. In view of this, investigating alternate regional blocks having the potential for good pain relief with minimal side effects is important. The Erector Spinae Plane (ESP) block can be considered as a modification of thoracic paravertebral block (PVB) that blocks thoracic spinal nerves using injections outside of the conventional paravertebral space. It is performed under ultrasound (US) by injecting local anesthetic deep to the erector spinae muscle at the interfascial space between either the erector spinae muscle and the rhomboid major muscle (higher up), or between the erector spinae muscle and the external intercostal muscles, at lower sites. Cadaveric studies of ultrasound-guided ESP blocks with methylene blue dye and subsequent dissection, as well an ESP block with a dye mixture and CT scanning demonstrated that when injecting deep into the erector spinae, the block likely affects the ventral and dorsal rami leading to the sensory blockade. The advantages include its simplicity and safety by limiting the risk of nerve damage and pneumothorax. Various case reports have demonstrated the ESP block to be successful for abdominal, breast and axillary, and other surgery types, and a recent case report described the successful management of chronic shoulder pain without motor blockade, with ESP performed at T3 level. The investigators conducted a systematic review via Pubmed to identify studies that have utilized ESP for post-surgical shoulder pain. Out of 77 reports, the investigators did not identify any comparative studies looking at the potential of ESP for shoulder surgery pain. The investigators also looked into ongoing and proposed trials of ESP by looking into clinicaltrials.gov. The investigators identified 21 studies including some randomized controlled trials (RCT) for thoracic surgery and general surgery population, but none for shoulder surgeries. Given the importance of providing adequate analgesia for arthroscopic shoulder surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, this trial will help establish the effectiveness of the ESP block in pain control after shoulder arthroscopy and define its safety profile. The results of this trial will allow the clinician to inform patients accurately regarding the benefits and risks of the block and thus guide the clinical practice of this block for shoulder arthroscopy. If proven to be effective, it may be used as an alternative to ISNB, especially in cases where ISNB is contraindicated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Active comparator | Procedure: Erector Spinae Plane (ESP) BlockPreoperative US guided active Erector Spinae Plane (ESP) block and a saline PAI |
| PAI with LA | Other | Procedure: Periarticular Infiltration (PAI)Preoperative US guided ESP blockade with saline and an active Periarticular Infiltration (PAI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective arthroscopic shoulder joint surgeries admitted for day surgical procedure
- an ability to provide informed consent
Key exclusion criteria (8 listed)
- not willing
- contraindications to spinal injections as per the American Society of Regional Anesthesia and Pain (ASRA) guidelines
- known allergy to LA
- allergy to all opioid medications
- diagnostic shoulder arthroscopic procedures
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 |
|---|---|---|
| Erector Spinae Plane (ESP) BlockAlso: 0.25% bupivacaine with 5 mcg/mL of epinephrine & PAI with 30 mL of saline1. Preoperative US guided ESP blockade using 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine, injected in 5-mL aliquots through the needle (maximum of 3 mg/kg) 2. PAI of 30 mL of saline at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle | Procedure or surgery | ESP Block |
| Periarticular Infiltration (PAI)Also: ESP block with 30 mL of saline & PAI with 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine1. Preoperative US guided ESP blockade using 30 mL of saline, injected in 5-mL aliquots through the needle 2. PAI of 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle | Procedure or surgery | PAI with LA |
Primary outcome
Recovery room resting pain score
Time frame: At 30 minutes post-admission to recovery room
Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
10 secondary outcomes
Day Surgery Unit resting pain score
Time frame: At 5 hours post-operatively
Pain scores with movement
Time frame: At 30 minutes post-admission to recovery room and 5 hours post-operatively
Opioid usage
Time frame: At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe postoperative nausea-vomiting
Time frame: At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe itching
Time frame: At 2 hours post-operatively and 5 hours post-operatively
Incidence of ipsilateral diaphragmatic paralysis
Time frame: 30 minutes post-admission to recovery room
Incidence of respiratory depression
Time frame: At 2 hours post-operatively and 5 hours post-operatively
Incidence of local anesthetic toxicity
Time frame: At 2 hours post-operatively and 5 hours post-operatively
Sensory blockade
Time frame: At 30 minutes post-admission to recovery room
Patient Satisfaction with Postoperative Analgesia
Time frame: At 5 hours post-operatively and 24 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 19593887Fontana C, Di Donato A, Di Giacomo G, Costantini A, De Vita A, Lancia F, Caricati A. Postoperative analgesia for arthroscopic shoulder surgery: a prospective randomized controlled study of intraarticular, subacromial injection, interscalenic brachial plexus block and intraarticular plus subacromial injection efficacy. Eur J Anaesthesiol. 2009 Aug;26(8):689-93. doi: 10.1097/eja.0b013e32832d673e.
- Background: PubMed 20859312Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010 Sep-Oct;13(5):401-35.
- Background: PubMed 9322460Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.
- Background: PubMed 11774146Barber FA, Herbert MA. The effectiveness of an anesthetic continuous-infusion device on postoperative pain control. Arthroscopy. 2002 Jan;18(1):76-81. doi: 10.1053/jars.2002.25976.
- Background: PubMed 22236345Merivirta R, Kuusniemi KS, Aantaa R, Hurme SA, Aarimaa V, Leino KA. The analgesic effect of continuous subacromial bupivacaine infusion after arthroscopic shoulder surgery: a randomized controlled trial. Acta Anaesthesiol Scand. 2012 Feb;56(2):210-6. doi: 10.1111/j.1399-6576.2011.02606.x.
- Background: PubMed 15122133Harvey GP, Chelly JE, AlSamsam T, Coupe K. Patient-controlled ropivacaine analgesia after arthroscopic subacromial decompression. Arthroscopy. 2004 May;20(5):451-5. doi: 10.1016/j.arthro.2004.03.004.
- Background: PubMed 27729319Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
- Background: PubMed 27079219Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.
- Background: PubMed 23903900Shin SW, Byeon GJ, Yoon JU, Ok YM, Baek SH, Kim KH, Lee SJ. Effective analgesia with ultrasound-guided interscalene brachial plexus block for postoperative pain control after arthroscopic rotator cuff repair. J Anesth. 2014 Feb;28(1):64-9. doi: 10.1007/s00540-013-1681-x. Epub 2013 Aug 1.
- 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 27575034Webb BG, Sallay PI, McMurray SD, Misamore GW. Comparison of Interscalene Brachial Plexus Block Performed With and Without Steroids. Orthopedics. 2016 Nov 1;39(6):e1100-e1103. doi: 10.3928/01477447-20160819-02. Epub 2016 Aug 30.
- Background: PubMed 15845712Candido KD, Sukhani R, Doty R Jr, Nader A, Kendall MC, Yaghmour E, Kataria TC, McCarthy R. Neurologic sequelae after interscalene brachial plexus block for shoulder/upper arm surgery: the association of patient, anesthetic, and surgical factors to the incidence and clinical course. Anesth Analg. 2005 May;100(5):1489-1495. doi: 10.1213/01.ANE.0000148696.11814.9F.
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Not yet recruitingPhase 4
Exparel and Dexamethasone
Postoperative Pain, Shoulder Arthroscopic Surgeries
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.
Harsha Shanthanna, MD principal investigator
St. Joseph's Healthcare Hamilton/McMaster University
Bashar Alolabi, MD principal investigator
St. Joseph's Healthcare Hamilton
Mark Czuczman, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane (ESP) Block and Periarticular Infiltration (PAI) in people with Arthroscopic Shoulder Surgery, run by McMaster University at 1 site in Canada.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 10 Aug 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recovery room resting pain score (time frame: At 30 minutes post-admission to recovery room). 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 NCT03691922, which also lists 20 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 10 Aug 2026.