Acute PainPhase 4NCT02527083
Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
A Phase 4 study testing Propofol, Sevoflurane and Remifentanil in people with Acute Pain and Chronic Pain, run by VA Pittsburgh Healthcare System.
Trial summary
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acute Pain, Chronic Pain, Hernia
- What is being tested?
- Propofol, Sevoflurane and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All male patients undergoing herniorrhaphy surgery that requires general anesthesia.
Who cannot join
- Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence.
- A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization.
- Pain-related disorders such as fibromyalgia or other chronic pain syndromes.
- Emergency surgery.
About this study
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.
- Being tested
- Propofol, Sevoflurane, Remifentanil, Ketamine
- Medical subject headings
- Acute Pain, Chronic Pain, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
SevofluraneDrug
Also called Ultane
RemifentanilDrug
Also called Ultiva
KetamineDrug
Also called Ketalar
| Study group | Role | What they receive |
|---|---|---|
| BIA | Active comparator | Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) Receives: Drug: Sevoflurane; Drug: Remifentanil |
| TIVA-K | Active comparator | Total intravenous anesthetic with ketamine Receives: Drug: Propofol; Drug: Ketamine |
| TIVA-R | Active comparator | Total intravenous anesthetic with remifentanil Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score, Chronic
Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.
Measured: 1 month, 3 months, 6 months, 12 months
Secondary outcomes (1)
Pain Score, Acute
Acute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527083
- Sponsor's protocol ID
- PRO00000878
- Status last verified
- May 2021
- First submitted
- 27 Jan 2015
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02527083
- Acronym / sponsor ID
- PRO00000878
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Study start
- Jan 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIA | Active comparator | Drug: Sevoflurane, Drug: RemifentanilBalanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only) |
| TIVA-K | Active comparator | Drug: Propofol, Drug: KetamineTotal intravenous anesthetic with ketamine |
| TIVA-R | Active comparator | Drug: Propofol, Drug: RemifentanilTotal intravenous anesthetic with remifentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All male patients undergoing herniorrhaphy surgery that requires general anesthesia.
Key exclusion criteria (4 listed)
- Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence.
- A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization.
- Pain-related disorders such as fibromyalgia or other chronic pain syndromes.
- Emergency surgery.
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 |
|---|---|---|
| PropofolAlso: Diprivan | Drug | TIVA-K, TIVA-R |
| SevofluraneAlso: Ultane | Drug | BIA |
| RemifentanilAlso: Ultiva | Drug | BIA, TIVA-R |
| KetamineAlso: Ketalar | Drug | TIVA-K |
Primary outcome
Pain Score, Chronic
Time frame: 1 month, 3 months, 6 months, 12 months
Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.
1 secondary outcome
Pain Score, Acute
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Sevoflurane and Remifentanil in people with Acute Pain and Chronic Pain, run by VA Pittsburgh Healthcare System.
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 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score, Chronic (time frame: 1 month, 3 months, 6 months, 12 months). 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 31 Dec 2025.