AzTrials
AzTrials

Total Shoulder ArthroplastyNCT07770165

Continuous Interscalene Blocks and Rebound Pain

A study testing Continuous interscalene nerve block and Interscalene Block in people with Total Shoulder Arthroplasty and Reverse Total Shoulder Arthroplasty, run by University of Calgary at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objectives of this present study are to examine whether a continuous interscalene block of a total duration of 48 hours reduces the incidence of rebound pain comparatively to single-shot interscalene block, through the evaluation of the NRS scores at rest and on movement in the postoperative period at 24… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Continuous interscalene nerve block and Interscalene Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteCanada
Study dates
Oct 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adults aged >18 years of age
  • ASA I-III
  • Scheduled for elective ambulatory total shoulder arthroplasty.

Who cannot join

  • ASA IV
  • Revision surgery
  • Contraindication to regional anesthesia (such as allergy to local anesthetics, systemic anticoagulation, local infection)
  • Preoperative chronic pain or opioid use
  • Preoperative drug dependency
  • Severe respiratory disease or contralateral diaphragmatic paralysis
  • Patient refusal.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • South Health Campus

    Calgary, Alberta, T3M 1M4

    Joanna Dr Fifen, MD, PhD, 403-956-3690, Joanna.Fifen@albertahealthservices.ca

    Joanna Fifen, MD, PhD

Other trials in Canada

About this study

Official title: Evaluation of the Effect of Continuous Interscalene Blocks on Rebound Pain Compared to Single-Shot Interscalene Blocks in Total Shoulder Arthroplasty : A Randomized-Controlled Trial

The primary objectives of this present study are to examine whether a continuous interscalene block of a total duration of 48 hours reduces the incidence of rebound pain comparatively to single-shot interscalene block, through the evaluation of the NRS scores at rest and on movement in the postoperative period at 24, 48, 72 and 96 hours as well as the total opioid consumption in the same timeframe for patients undergoing total shoulder arthroplasty.

Rebound pain has been defined in some studies as the "the transition from well-controlled pain (numerical rating scale [NRS] ≤3) while the block is working to severe pain (NRS ≥7) within 24 h of block performance."

Read the detailed description

The number of patients requiring shoulder replacements for many different indications, including osteoarthritis, cuff arthropathy and acute fractures has continually grown in the last 15 years, as suggested by a recent international meta-analysis. While there is no designated Canadian database specific to total shoulder arthroplasty compiled by the Canadian Institute for Health Information (CIHI), international data suggests that the expansion of the indications for reverse total shoulder replacements has contributed to the increase in the total amount of patients that undergo such procedure, with an estimated growth of 6-15% between 2011 and 2019. Moreover, there has also been a four-fold increase in the proportion of outpatient shoulder arthroplasty cases in an ACS-NSQIP database from 2015-2019, without a notable increase in adverse patient events, highlighting a shift towards a more ambulatory approach to total shoulder arthroplasty (TSA).

As this procedure becomes mostly ambulatory, new challenges arise regarding the best pain management modality to limit the overall need for opioids and reduce their side effects including respiratory depression, pruritis, nausea and vomiting, as well as increasing patient satisfaction and recovery. There are multiple anesthetic techniques described in the literature to aid in multimodal analgesia, the most commonly used being the interscalene block (ISB), as a single-shot (sISB) or as a continuous infusion (cISB), often combined with multimodal analgesia with dexamethasone and dexmedetomidine. Other techniques include superior trunk blocks, as well as suprascapular nerve block, often used as an alternative when respiratory complications are a major concern due to phrenic nerve blockade. Most regional analgesia techniques detailed above have shown superior pain management compared to local infiltration alone.

Although the interscalene block is clearly established as standard of care for all patients undergoing shoulder surgery, numerous studies have compared the efficacy of sISB versus catheter-based cISB, with variable results favoring either modality in terms of pain management, opioid consumption and patient-related side effects. A more recent systematic review and meta-analysis of over 1000 patients in 20 trials on the effects of single-injection vs. continuous brachial plexus blocks for shoulder surgeries on patient-reported outcomes published in June 2026 has highlighted better pain management for cISB than sISB, especially during the 12- to 48-hour period, although most of the regimens showing better analgesia also included patient-controlled boluses. Notably, mean pain at rest was lower in the cISB group, with a particular benefit in the 24-48 hour period, a period where the concept of "rebound pain" can occur with single-shot modalities.

This concept has been defined in some studies as the "the transition from well-controlled pain (numerical rating scale [NRS] ≤3) while the block is working to severe pain (NRS ≥7) within 24 h of block performance.", with an estimated occurrence of 49.6%. Some identified contributors were younger patients, female gender, surgery involving bone, the absence of IV dexamethasone, as well as upper limb surgery. A possible explanation relies on a "supply-vs-demand" mismatch, where the possible analgesic block could be of insufficient length compared to the patient's needs, especially in the at-risk populations. A study realized in 2007 on femoral nerve block proved that prolonging a nerve block with a catheter based infusion did reduce the apparition of rebound pain. This concept has yet to be formally evaluated in upper limb surgeries and blocks, including in total shoulder arthroplasty.

Being tested
Continuous interscalene nerve block, Interscalene Block
Keywords
Interscalene, Nerve Block, Catheter, Continuous Interscalene Block, Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty, Rebound Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous interscalene nerve blockDrug

    This Interventional Group will receive a continuous interscalene block via a catheter for a duration of 48 hours with ropivacaine 0.2% at a fixed 5 mL/hour rate.

  • Interscalene BlockDrug

    This control group will receive a single shot interscalene block with 20 mL of ropivicaine 0.2%.

Study groups in NCT07770165
Study groupRoleWhat they receive
Single Shot Interscalene BlockActive comparatorThis Control Group will receive a single-shot interscalene block, which is considered one of the standard of care analgesic modality for shoulder surgery.
Receives: Drug: Interscalene Block
Continuous Interscalene BlockExperimentalThis Interventional Group will receive a continuous interscalene block via a catheter for a duration of 48 hours with ropivacaine 0.2% at a fixed 5 mL/hour rate.
Receives: Drug: Continuous interscalene nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of Rebound pain within 96 hours postoperatively

    The incidence of Rebound Pain, defined as an NRS score of < 3 during an effective block to an NRS > 7 within 24 hours of block resolution. This will be analyzed as a binary variable (yes/no)

    Measured: This outcome will be measured within 24 hours of block resolution, for up to 96 hours after the initial block realization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
Model description
This is a pragmatic randomized controlled, parallel group, single-blinded trial comparing a single-shot interscalene block (control group) to a catheter-based continuous interscalene block (treatment group) placed preoperatively in total shoulder arthroplasty patients.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770165
Sponsor's protocol ID
REB26-1309
Status last verified
Jul 2026
First submitted
12 Aug 2026
Last updated
19 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • https://www.sciencedirect.com/science/article/pii/S2950553424000856

  • https://www.sciencedirect.com/science/article/pii/S0972978X20301756?via%3Dihub#bib20

  • https://www.nysora.com/regional-anesthesia/techniques/upper-extremity/intescalene/ultrasound-guided-interscalene-brachial-plexus-block/

  • https://www.ovid.com/jnls/co-anesthesiology/fulltext/10.1097/aco.0000000000000651~rebound-pain-after-regional-anesthesia-in-the-ambulatory

  • https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.16583

  • https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.70249

  • Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.

    PubMed 17543812
  • Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.

    PubMed 33390261
  • Rhyner P, Cachemaille M, Goetti P, Rossel JB, Boand M, Farron A, Albrecht E. Single-bolus injection of local anesthetic, with or without continuous infusion, for interscalene brachial plexus block in the setting of multimodal analgesia: a randomized controlled unblinded trial. Reg Anesth Pain Med. 2024 May 7;49(5):313-319. doi: 10.1136/rapm-2023-104681.

    PubMed 37541683
  • Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.

    PubMed 28968280
  • Kim HJ, Koh KH, Park JI, Kim YJ, Kim MJ, Kim H, Kim H, Ro YJ, Koh WU. Comparison of the Analgesic Efficacy between Arthroscopically Placed Continuous Suprascapular Nerve Block and Ultrasound-guided Continuous Superior Trunk Block: A Double-blinded Randomized Controlled Trial. Anesthesiology. 2023 Nov 1;139(5):591-601. doi: 10.1097/ALN.0000000000004691.

    PubMed 37450621
  • Pai B H P, Bohaczuk S, Jinadu S, Hong J, Echevarria G, Lai YH, Chen J, Cagle PJ, Flatow EL, Rosenblatt M. Comparison of analgesic efficacy of continuous perineural catheter, liposomal bupivacaine, and dexamethasone as an adjuvant for interscalene block in total shoulder arthroplasty: a triple-blinded randomized controlled trial. J Shoulder Elbow Surg. 2025 Feb;34(2):e81-e92. doi: 10.1016/j.jse.2024.06.014. Epub 2024 Aug 27.

    PubMed 39197650
  • Xiao M, Cohen SA, Cheung EV, Freehill MT, Abrams GD. Pain management in shoulder arthroplasty: a systematic review and network meta-analysis of randomized controlled trials. J Shoulder Elbow Surg. 2021 Nov;30(11):2638-2647. doi: 10.1016/j.jse.2021.06.008. Epub 2021 Jul 17.

    PubMed 34284094
  • Trudeau MT, Peters JJ, LeVasseur MR, Hawthorne BC, Dorsey CG, Wellington IJ, Shea KP, Mazzocca AD. Inpatient versus outpatient shoulder arthroplasty outcomes: A propensity score matched risk-adjusted analysis demonstrates the safety of outpatient shoulder arthroplasty. J ISAKOS. 2022 Apr;7(2):51-55. doi: 10.1016/j.jisako.2022.01.001. Epub 2022 Jan 25.

    PubMed 35546436
  • Woodmass J, Harris S, McRae S, Righolt CH, MacDonald P, Bohm E. Implementation of and findings from a regional shoulder replacement registry. Can J Surg. 2026 Mar 31;69(2):E137-E145. doi: 10.1503/cjs.014624. Print 2026 Mar-Apr.

    PubMed 41916651

Questions about this trial

What is this clinical trial studying?

A study testing Continuous interscalene nerve block and Interscalene Block in people with Total Shoulder Arthroplasty and Reverse Total Shoulder Arthroplasty, run by University of Calgary 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of Rebound pain within 96 hours postoperatively (time frame: This outcome will be measured within 24 hours of block resolution, for up to 96 hours after the initial block realization.). 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 NCT07770165, which also lists 16 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 19 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in