PainEXPECTNCT05733039
Association of Expectations and Pain Relief After Diagnostic Nerve Blocks
An observational study of Pain and Expectations, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Expectations are a major driver of changes in health-related outcomes and are related to reduced pain after medical treatment. However, no studies have specifically addressed the role of expectations in connection with the success of interventional pain techniques and the specific effect of expectations on diagnostic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Expectations
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 3 Feb 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All referred pain patients (acute and chronic), scheduled for a first diagnostic nerve block.
Who may be able to join
- referral to our pain clinic
- interventions: Lumbar medial branch block or greater occipital nerve block, both with lidocaine 2%
Who cannot join
- Psychiatric co-morbidities other than depression
- Inability to express pain scores on a numeric rating scale
- Refusal of informed consent
- Insufficient knowledge of German, French or English
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, Bern University Hospital
Bern, Canton of Bern, 3010
About this study
Official title: Association of Expectations and Pain Relief After Diagnostic Nerve Blocks (EXPECT) - A Prospective Cohort Study
Expectations are a major driver of changes in health-related outcomes and are related to reduced pain after medical treatment. However, no studies have specifically addressed the role of expectations in connection with the success of interventional pain techniques and the specific effect of expectations on diagnostic and therapeutic procedures in this field. Further, there are no studies on prolonged pain reduction after diagnostic nerve blocks. This prospective cohort study will investigate patients' outcome-related expectations measured by validated questionnaires (i.a. the Expectation for Treatment Scale) before standardized diagnostic nerve blocks (i.e. lumbar medial branch and greater occipital nerve blocks) and their association with immediate pain reduction, calculated using a numeric rating scale (NRS) before and after the block. Secondary outcomes are specificity of pain relief duration in relation to the local anesthetic, changes in pain-related interference, quality of life and function, as well as patients' global impression of change after one week in order to assess possible therapeutic effects of the nerve blocks themselves. The sample size of 110 patients is based on a power of 80% and a significance level of 0.05. Additional endpoints will be evaluated using mixed-effects linear regression, non-linear relationships between expectation and endpoints will be modelled using fractional polynomials. This research will quantify the effect of patients' expectations on pain reduction after nerve blocks, extend our knowledge which patients are likely to respond to interventional pain treatments and under which circumstances nerve blocks may exhibit therapeutic effects.
Read the detailed description
Expectations are a major driver of change in health-related outcomes and are related to reduced pain after medical treatment. However, studies on expectations and their relation to pain relief after nerve blocks are largely lacking and there is a paucity of high-quality research in this area. These blocks are frequently used in interventional pain therapy to confirm a particular diagnosis (diagnostic blocks), and to predict if a patient could profit from a particular therapy (prognostic blocks). To current knowledge, there are no studies that specifically assess the association of expectation and response to pain relief after nerve blocks. A further aspect is longer lasting pain relief (i.e. sometimes for days or even weeks) that is sometimes observed in clinical practice after diagnostic nerve blocks and often attributed to a placebo effect. This may lead clinicians to perform block "series" in a therapeutic attempt. Such efforts can be controversial, since the duration of action of local anesthetics is limited to a few hours only - e.g. typically to 2-4 hours in the case of lidocaine, a short acting amino amide and one of the most widely used substances.
There are no investigations on prolonged pain relief after nerve blocks and despite decades of their use in clinical practice, there is hardly any research available.
Hypothesis and primary objective The investigators' goal is to evaluate the association of patients' outcome-related expectations with the short-term success of diagnostic blocks and to assess whether expectations contribute to longer-lasting therapeutic effects. Therefore, they will conduct a prospective cohort study of patients receiving diagnostic nerve blocks in our tertiary pain clinic. According to current recommendations on clinical outcome assessment, pain intensity, physical functioning, emotional functioning and ratings of improvements are all collected. We hypothesize that expectations play a major role in the extent of pain relief in % as well as its duration after the application of local anesthetics, i.e. in this case longer than 2-4 hours for lidocaine.
They will also analyze other potentially influential factors such as depressive symptoms, anxiety and catastrophizing - these are secondary objectives. Thus, they aim to quantify the effect of expectations, assess the therapeutic potential of nerve blocks, improve the accuracy of pretests and exclude patients from clinical pathways who are unlikely to profit from them.
- Conditions
- Pain, Expectations
- Keywords
- Pain, Expectations, Local anaesthetic, Pain treatment
- Medical subject headings
- Pain, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Change in pain intensity directly after the diagnostic nerve block, calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain) before and 30 minutes after the nerve block.
Measured: 30 minutes
Secondary outcomes (4)
Change in pain intensity (longterm)
Change in pain intensity on the same day and during one week after diagnostic block, calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain).
Measured: 1 week
Specificity of local anesthetic
Specificity of local anesthetic within one day after diagnostic block (duration of pain relief corresponds to substance: yes/no)
Measured: 1 day
Pain-related disability after 1 week
Pain-related disability using the Brief Pain Inventory: Pain severities for worst, least, average and actual pain are calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain). The 7 interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely.
Measured: 1 week
Patient Global Impression of Change (PGIC) after 1 week
Patient Global Impression of Change (PGIC) one week after diagnostic block with the items "pain intensity", "quality of life" and "ability to function", measured on a 7-point scale (1="very much better", 7="very much worse")
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jun 2021
- Primary completion1 Feb 2024
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Harnik, Insel Gruppe AG, University Hospital Bern
- Investigators
- Michael Harnik, Dr. med., Principal investigator, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733039
- Sponsor's protocol ID
- EXPECT 2021-00459
- Acronym
- EXPECT
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Expectations and Pain Relief After Diagnostic Nerve Blocks (EXPECT) - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05733039
- Acronym / sponsor ID
- EXPECT / EXPECT 2021-00459
- Conditions
- Pain, Expectations
- Keywords
- Pain, Expectations, Local anaesthetic, Pain treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 17 Feb 2023 (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.
Expectations are a major driver of changes in health-related outcomes and are related to reduced pain after medical treatment. However, no studies have specifically addressed the role of expectations in connection with the success of interventional pain techniques and the specific effect of expectations on diagnostic and therapeutic procedures in this field. Further, there are no studies on prolonged pain reduction after diagnostic nerve blocks. This prospective cohort study will investigate patients' outcome-related expectations measured by validated questionnaires (i.a. the Expectation for Treatment Scale) before standardized diagnostic nerve blocks (i.e. lumbar medial branch and greater occipital nerve blocks) and their association with immediate pain reduction, calculated using a numeric rating scale (NRS) before and after the block. Secondary outcomes are specificity of pain relief duration in relation to the local anesthetic, changes in pain-related interference, quality of life and function, as well as patients' global impression of change after one week in order to assess possible therapeutic effects of the nerve blocks themselves. The sample size of 110 patients is based on a power of 80% and a significance level of 0.05. Additional endpoints will be evaluated using mixed-effects linear regression, non-linear relationships between expectation and endpoints will be modelled using fractional polynomials. This research will quantify the effect of patients' expectations on pain reduction after nerve blocks, extend our knowledge which patients are likely to respond to interventional pain treatments and under which circumstances nerve blocks may exhibit therapeutic effects.
Detailed description
Expectations are a major driver of change in health-related outcomes and are related to reduced pain after medical treatment. However, studies on expectations and their relation to pain relief after nerve blocks are largely lacking and there is a paucity of high-quality research in this area. These blocks are frequently used in interventional pain therapy to confirm a particular diagnosis (diagnostic blocks), and to predict if a patient could profit from a particular therapy (prognostic blocks). To current knowledge, there are no studies that specifically assess the association of expectation and response to pain relief after nerve blocks. A further aspect is longer lasting pain relief (i.e. sometimes for days or even weeks) that is sometimes observed in clinical practice after diagnostic nerve blocks and often attributed to a placebo effect. This may lead clinicians to perform block "series" in a therapeutic attempt. Such efforts can be controversial, since the duration of action of local anesthetics is limited to a few hours only - e.g. typically to 2-4 hours in the case of lidocaine, a short acting amino amide and one of the most widely used substances.
There are no investigations on prolonged pain relief after nerve blocks and despite decades of their use in clinical practice, there is hardly any research available.
Hypothesis and primary objective The investigators' goal is to evaluate the association of patients' outcome-related expectations with the short-term success of diagnostic blocks and to assess whether expectations contribute to longer-lasting therapeutic effects. Therefore, they will conduct a prospective cohort study of patients receiving diagnostic nerve blocks in our tertiary pain clinic. According to current recommendations on clinical outcome assessment, pain intensity, physical functioning, emotional functioning and ratings of improvements are all collected. We hypothesize that expectations play a major role in the extent of pain relief in % as well as its duration after the application of local anesthetics, i.e. in this case longer than 2-4 hours for lidocaine.
They will also analyze other potentially influential factors such as depressive symptoms, anxiety and catastrophizing - these are secondary objectives. Thus, they aim to quantify the effect of expectations, assess the therapeutic potential of nerve blocks, improve the accuracy of pretests and exclude patients from clinical pathways who are unlikely to profit from them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All referred pain patients (acute and chronic), scheduled for a first diagnostic nerve block.
Key inclusion criteria (2 listed)
- referral to our pain clinic
- interventions: Lumbar medial branch block or greater occipital nerve block, both with lidocaine 2%
Key exclusion criteria (4 listed)
- Psychiatric co-morbidities other than depression
- Inability to express pain scores on a numeric rating scale
- Refusal of informed consent
- Insufficient knowledge of German, French or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pain intensity
Time frame: 30 minutes
Change in pain intensity directly after the diagnostic nerve block, calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain) before and 30 minutes after the nerve block.
4 secondary outcomes
Change in pain intensity (longterm)
Time frame: 1 week
Specificity of local anesthetic
Time frame: 1 day
Pain-related disability after 1 week
Time frame: 1 week
Patient Global Impression of Change (PGIC) after 1 week
Time frame: 1 week
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 7 Jul 2026.
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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.
Michael Harnik, Dr. med. principal investigator
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital
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 Pain and Expectations, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 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 7 Jul 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 Switzerland. 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?
Change in pain intensity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.