Regional Anesthesia MorbidityNCT05357105
Rebound Pain Following Surgery With Regional Anesthesia Block
An observational study of Regional Anesthesia Morbidity and Pain, Postoperative, run by University of Alberta at 1 site in Canada.
Trial summary
For some kinds of surgery, Anesthesiologists provide nerve blocks (regional anesthesia) to reduce pain from surgery by injecting freezing medication around deep nerves with ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Regional Anesthesia Morbidity, Pain, Postoperative
- What is being tested?
- Numerical Pain Scales
- How many people
- 119 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2023to 15 Jan 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients 18-75 years who are receiving peripheral nerve block as part for anesthesia/analgesia as part of standard perioperative care for surgery performed at University of Alberta Hospital.
Who may be able to join
- Age 18-75 years
- Receiving peripheral nerve block as part for anesthesia/analgesia as part of standard perioperative care for surgery performed at University of Alberta Hospital during a 6 month period
- Elective and emergency surgery
Who cannot join
- Inability to consent to participate in the study (illiteracy, <7th grade education)
- Contraindication/history of hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rebound Pain Following Surgery With Regional Anesthesia Block: A Prospective Cohort Study
For some kinds of surgery, Anesthesiologists provide nerve blocks (regional anesthesia) to reduce pain from surgery by injecting freezing medication around deep nerves with ultrasound. Nerve blocks help with pain control following surgery and reduce the amount of strong opioids needed but relatively little research has focused on the pain that occurs once the nerve block has worn off. This is called rebound or transition pain.
This research study will prospectively collect data including pain scores before, during and after nerve blocks are given for surgery. We will look at the type of nerve blocks and other analgesia medications used with the aim of quantifying rebound pain to better understand how to limit it's impact on quality postoperative pain control.
- Conditions
- Regional Anesthesia Morbidity, Pain, Postoperative
- Being tested
- Numerical Pain Scales
- Keywords
- Rebound Pain, Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numerical Pain ScalesOther
Patients who are about to receive regional nerve blocks will be administered a numerical pain scale (NRS) before, during and after the offset of the nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Regional Nerve Block Patients | Patients who receive regional nerve blocks as part of the anesthetic management prior to surgery. Receives: Other: Numerical Pain Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale
Measured: 2-3 times per patient over the course of a nerve block, up to 48 hours after the stop of the block (single shot or cessation of nerve catheter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Jan 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Green, MD, Principal investigator, University of Alberta Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357105
- Sponsor's protocol ID
- ReboundPain
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koepke EJ, Manning EL, Miller TE, Ganesh A, Williams DGA, Manning MW. The rising tide of opioid use and abuse: the role of the anesthesiologist. Perioper Med (Lond). 2018 Jul 3;7:16. doi: 10.1186/s13741-018-0097-4. eCollection 2018.
PubMed 29988696Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Sunderland S, Yarnold CH, Head SJ, Osborn JA, Purssell A, Peel JK, Schwarz SK. Regional Versus General Anesthesia and the Incidence of Unplanned Health Care Resource Utilization for Postoperative Pain After Wrist Fracture Surgery: Results From a Retrospective Quality Improvement Project. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):22-7. doi: 10.1097/AAP.0000000000000325.
PubMed 26650425Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
PubMed 30124544Barry 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Pain Following Surgery With Regional Anesthesia Block: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05357105
- Acronym / sponsor ID
- ReboundPain
- Conditions
- Regional Anesthesia Morbidity, Pain, Postoperative
- Keywords
- Rebound Pain, Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 May 2022 (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.
For some kinds of surgery, Anesthesiologists provide nerve blocks (regional anesthesia) to reduce pain from surgery by injecting freezing medication around deep nerves with ultrasound. Nerve blocks help with pain control following surgery and reduce the amount of strong opioids needed but relatively little research has focused on the pain that occurs once the nerve block has worn off. This is called rebound or transition pain.
This research study will prospectively collect data including pain scores before, during and after nerve blocks are given for surgery. We will look at the type of nerve blocks and other analgesia medications used with the aim of quantifying rebound pain to better understand how to limit it's impact on quality postoperative pain control.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional Nerve Block Patients | – | Other: Numerical Pain ScalesPatients who receive regional nerve blocks as part of the anesthetic management prior to surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 18-75 years who are receiving peripheral nerve block as part for anesthesia/analgesia as part of standard perioperative care for surgery performed at University of Alberta Hospital.
Key inclusion criteria (3 listed)
- Age 18-75 years
- Receiving peripheral nerve block as part for anesthesia/analgesia as part of standard perioperative care for surgery performed at University of Alberta Hospital during a 6 month period
- Elective and emergency surgery
Key exclusion criteria (2 listed)
- Inability to consent to participate in the study (illiteracy, <7th grade education)
- Contraindication/history of hypersensitivity to local anesthetics
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 |
|---|---|---|
| Numerical Pain ScalesPatients who are about to receive regional nerve blocks will be administered a numerical pain scale (NRS) before, during and after the offset of the nerve block. | Other | Regional Nerve Block Patients |
Primary outcome
Numerical Pain Scale
Time frame: 2-3 times per patient over the course of a nerve block, up to 48 hours after the stop of the block (single shot or cessation of nerve catheter)
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 4 Mar 2025.
- Background: PubMed 29988696Koepke EJ, Manning EL, Miller TE, Ganesh A, Williams DGA, Manning MW. The rising tide of opioid use and abuse: the role of the anesthesiologist. Perioper Med (Lond). 2018 Jul 3;7:16. doi: 10.1186/s13741-018-0097-4. eCollection 2018.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 26650425Sunderland S, Yarnold CH, Head SJ, Osborn JA, Purssell A, Peel JK, Schwarz SK. Regional Versus General Anesthesia and the Incidence of Unplanned Health Care Resource Utilization for Postoperative Pain After Wrist Fracture Surgery: Results From a Retrospective Quality Improvement Project. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):22-7. doi: 10.1097/AAP.0000000000000325.
- Background: PubMed 30124544Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.
- Background: PubMed 33390261Barry 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.
- Individual participant dataSharing planned: No
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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.
James Green, MD principal investigator
University of Alberta Department of Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity and Pain, Postoperative, run by University of Alberta 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 2 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 4 Mar 2025. 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?
Numerical Pain Scale (time frame: 2-3 times per patient over the course of a nerve block, up to 48 hours after the stop of the block (single shot or cessation of nerve catheter)). 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 NCT05357105, which also lists 5 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 4 Mar 2025.