PainNCT05635383
REBOUND PAIN AFTER PERIPHERAL NERVE BLOCKS
An observational study of Pain and Block, run by Diskapi Yildirim Beyazit Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
In recent years, the use of regional anesthesia techniques as part of multimodal analgesia strategies to maximize pain control in patients has reduced opioid requirements and promoted early mobility and rehabilitation in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- PERIPHERAL NERVE BLOCK
- How many people
- 386 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 12 Mar 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged >18 years who underwent orthopedic surgery with the peripheral nerve block will be included in the study.
Who may be able to join
- Patients aged >18 years who underwent orthopedic surgery with the peripheral nerve block
Who cannot join
- Patients who did not want to participate in the study
- dementia
- severe psychiatric or cognitive dysfunction
- coagulopathy
- neuropathic disorder
- local anesthetic allergy
- serious heart-lung disease
- chronic opioid use
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Medical Science, Yıldırım Beyazıt Training and Research Hospital
Ankara, 06000
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara
About this study
Official title: Investigation of the Frequency and Causes of Rebound Pain Phenomenon After Peripheral Nerve Blocks
In recent years, the use of regional anesthesia techniques as part of multimodal analgesia strategies to maximize pain control in patients has reduced opioid requirements and promoted early mobility and rehabilitation in the perioperative period. Regional anesthesia has benefits, mainly peripheral nerve blocks (PNB), muscle relaxation, and postoperative analgesia, thus allowing for control of postoperative pain and early discharge from the hospital. In addition, using PNB techniques provides:
Hemodynamic stability. Reduced need for a post-anesthetic care unit (PACU). Reduced unplanned hospitalization for pain control. Less airway management. Reduced incidence of opioid-related adverse events. Greater patient satisfaction
Read more
The main feature of rebound pain is that it is severe pain, within 8-24 hours after PNB. It usually remains severe for 2-6 hours, but the subsequent pain trajectory is consistent with the recovery process expected at surgical intervention. Therefore, rebound pain is temporary and different from persistent post-surgical pain (PPSP).
Rebound pain often occurs at night. However, this is probably related to the 8 to 12-hour duration of most single-injection PNBs and the completion of most elective surgeries during daylight hours.
Read the detailed description
This study aims to reveal the rebound pain profile, determine the risk factors, and contribute to developing strategies that can prevent rebound pain.
- Being tested
- PERIPHERAL NERVE BLOCK
- Keywords
- REBOUND PAIN, PERIPHERAL NERVE BLOCKS, analgesia
- Medical subject headings
- Pain, Bites and Stings, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERIPHERAL NERVE BLOCKOther
Observation of rebound pain after peripheral nerve block application
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of rebound pain
Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.
Measured: perioperative period
Secondary outcomes (1)
rebound pain risk factors
such as age, gender, and presence of preoperative pain.
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635383
- Sponsor's protocol ID
- 9.5.2022 137/01
- Status last verified
- Mar 2024
- First submitted
- 23 Nov 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 17543812Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.
PubMed 19542791Lavand'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 30124544Atar F, Ozkan Sipahioglu F, Karaca Akaslan F, Macit Aydin E, Sezer E, Ozkan D. Frequency of rebound pain and related factors in a multimodal regimen including systemic dexamethasone and dexmedetomidine. Anaesthesiologie. 2025 Mar;74(3):148-155. doi: 10.1007/s00101-025-01502-z. Epub 2025 Feb 24.
PubMed 39992389
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Frequency and Causes of Rebound Pain Phenomenon After Peripheral Nerve Blocks
- ClinicalTrials.gov ID
- NCT05635383
- Acronym / sponsor ID
- 9.5.2022 137/01
- Keywords
- REBOUND PAIN, PERIPHERAL NERVE BLOCKS, analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 2 Dec 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.
In recent years, the use of regional anesthesia techniques as part of multimodal analgesia strategies to maximize pain control in patients has reduced opioid requirements and promoted early mobility and rehabilitation in the perioperative period. Regional anesthesia has benefits, mainly peripheral nerve blocks (PNB), muscle relaxation, and postoperative analgesia, thus allowing for control of postoperative pain and early discharge from the hospital. In addition, using PNB techniques provides:
Hemodynamic stability. Reduced need for a post-anesthetic care unit (PACU). Reduced unplanned hospitalization for pain control. Less airway management. Reduced incidence of opioid-related adverse events. Greater patient satisfaction
The main feature of rebound pain is that it is severe pain, within 8-24 hours after PNB. It usually remains severe for 2-6 hours, but the subsequent pain trajectory is consistent with the recovery process expected at surgical intervention. Therefore, rebound pain is temporary and different from persistent post-surgical pain (PPSP).
Rebound pain often occurs at night. However, this is probably related to the 8 to 12-hour duration of most single-injection PNBs and the completion of most elective surgeries during daylight hours.
Detailed description
This study aims to reveal the rebound pain profile, determine the risk factors, and contribute to developing strategies that can prevent rebound pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged >18 years who underwent orthopedic surgery with the peripheral nerve block will be included in the study.
Key inclusion criteria (1 listed)
- Patients aged >18 years who underwent orthopedic surgery with the peripheral nerve block
Key exclusion criteria (8 listed)
- Patients who did not want to participate in the study
- dementia
- severe psychiatric or cognitive dysfunction
- coagulopathy
- neuropathic disorder
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 |
|---|---|---|
| PERIPHERAL NERVE BLOCKObservation of rebound pain after peripheral nerve block application | Other | – |
Primary outcome
incidence of rebound pain
Time frame: perioperative period
Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.
1 secondary outcome
rebound pain risk factors
Time frame: perioperative period
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 28 Mar 2024.
- Background: PubMed 17543812Williams 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.
- Background: PubMed 19542791Gramke HF, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Sommer M, Marcus MA. Predictive factors of postoperative pain after day-case surgery. Clin J Pain. 2009 Jul-Aug;25(6):455-60. doi: 10.1097/AJP.0b013e31819a6e34.
- Results publication: 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.
- Derived from this study: PubMed 39992389Atar F, Ozkan Sipahioglu F, Karaca Akaslan F, Macit Aydin E, Sezer E, Ozkan D. Frequency of rebound pain and related factors in a multimodal regimen including systemic dexamethasone and dexmedetomidine. Anaesthesiologie. 2025 Mar;74(3):148-155. doi: 10.1007/s00101-025-01502-z. Epub 2025 Feb 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Block, run by Diskapi Yildirim Beyazit Education and Research Hospital at 2 sites in Turkey (Türkiye).
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 1 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
incidence of rebound pain (time frame: perioperative period). 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 NCT05635383, which also lists 4 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 28 Mar 2024.