PainPhase 4NCT01480765
Preventing Pain After Heart Surgery
A Phase 4 study testing Pregabalin and Ketamine infusion in people with Pain and Hyperalgesia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Hyperalgesia, Chronic Illness
- What is being tested?
- Pregabalin and Ketamine infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2011to 7 Mar 2013
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- First time sternotomy for all cardiac surgery
- Patient aged 18 - 80 years
Who cannot join
- Emergency surgery (decision to operate taken on the day of surgery)
- Previous sternotomy
- Preoperative renal failure (eGFR <60 ml/min)
- History of chronic non-anginal pain
- Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
- Concurrent use of oxycodone, lorazepam, or ethanol.
Show all 11Show fewer
- Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
- Allergy to pregabalin, gabapentin or ketamine
- Pregnancy
- Limited understanding of numerical scoring scales
- Previous participation in other trials investigating analgesic agents or any IMP in previous three months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pain and Ananesthesia Research Centre, Barts and The London NHS Trust
London, EC1A 7BE
About this study
Official title: Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
- Conditions
- Pain, Hyperalgesia, Chronic Illness, Neuropathic Pain
- Being tested
- Pregabalin, Ketamine infusion, Placebo capsules, Placebo infusion
- Medical subject headings
- Pain, Hyperalgesia, Chronic Disease, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
Ketamine infusionDrug
0.1mg/kg/hr for 48 hours post operatively
Placebo capsulesDrug
Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days
Placebo infusionDrug
Normal saline placebo intravenous infusion for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Control: Placebo + Placebo | Placebo comparator | Placebo capsules and Placebo infusion Receives: Drug: Placebo capsules; Drug: Placebo infusion |
| Pregabalin and Placebo infusion | Active comparator | Pregabalin capsules and Placebo infusion Receives: Drug: Pregabalin; Drug: Placebo infusion |
| Pregabalin + Ketamine infusion | Active comparator | Pregabalin capsules + Ketamine infusion Receives: Drug: Pregabalin; Drug: Ketamine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
Measured: 3 and 6 months post sternotomy
Secondary outcomes (11)
Total morphine consumption at 24 hours post surgery
Measured: 24 hours post surgery
Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
Measured: 24 hours post surgery
Sedation (including pCO2) and nausea scores at 24 hours post surgery
Measured: 24 hours post surgery
Side effect episodes (dizziness, confusion, blurred vision)
Measured: First 48 hours
Time to extubation
Measured: Post op recovery period
Length of stay in intensive care and hospital
Measured: Post operative - acute
28 day mortality
Measured: 28 days post surgery
Neuropathic pain score
S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
Measured: 3 and 6 months post surgery
Quality of Life
EQ-5D validated scoring scale
Measured: 3 and 6 months
Survival
Measured: 3 and 6 months
QST measurements
Pain Pressure Thresholds (PPT) using algometry, both pre and post Diffuse Noxious Inhibitory Control (DNIC) Tactile and Pain Detection Thresholds with mechanical static stimulus using Von Frey hairs (VFH) Dynamic assessment of temporal summation and secondary hyeralgesia with VFH
Measured: Pre op and post op at 72hrs and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study start12 Dec 2011
- Primary completion7 Mar 2013
- Study completion7 Mar 2013
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sibtain Anwar, MA MB FRCA, Study director, Barts and The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480765
- Sponsor's protocol ID
- Reda 007583
- Other IDs
- 2010-024462-21, 11/H0703/7
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2011
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT01480765
- Acronym / sponsor ID
- Reda 007583
- Conditions
- Pain, Hyperalgesia, Chronic Illness, Neuropathic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 12 Dec 2011
- Primary completion
- 7 Mar 2013 (actual)
- Study completion
- 7 Mar 2013 (actual)
- First posted
- 29 Nov 2011 (estimated)
- 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.
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control: Placebo + Placebo | Placebo comparator | Drug: Placebo capsules, Drug: Placebo infusionPlacebo capsules and Placebo infusion |
| Pregabalin and Placebo infusion | Active comparator | Drug: Pregabalin, Drug: Placebo infusionPregabalin capsules and Placebo infusion |
| Pregabalin + Ketamine infusion | Active comparator | Drug: Pregabalin, Drug: Ketamine infusionPregabalin capsules + Ketamine infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent
- First time sternotomy for all cardiac surgery
- Patient aged 18 - 80 years
Key exclusion criteria (11 listed)
- Emergency surgery (decision to operate taken on the day of surgery)
- Previous sternotomy
- Preoperative renal failure (eGFR <60 ml/min)
- History of chronic non-anginal pain
- Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
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 |
|---|---|---|
| Pregabalin150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days | Drug | Pregabalin + Ketamine infusion, Pregabalin and Placebo infusion |
| Ketamine infusion0.1mg/kg/hr for 48 hours post operatively | Drug | Pregabalin + Ketamine infusion |
| Placebo capsulesSingle capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days | Drug | Control: Placebo + Placebo |
| Placebo infusionNormal saline placebo intravenous infusion for 48 hours | Drug | Control: Placebo + Placebo, Pregabalin and Placebo infusion |
Primary outcome
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
Time frame: 3 and 6 months post sternotomy
11 secondary outcomes
Total morphine consumption at 24 hours post surgery
Time frame: 24 hours post surgery
Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
Time frame: 24 hours post surgery
Sedation (including pCO2) and nausea scores at 24 hours post surgery
Time frame: 24 hours post surgery
Side effect episodes (dizziness, confusion, blurred vision)
Time frame: First 48 hours
Time to extubation
Time frame: Post op recovery period
Length of stay in intensive care and hospital
Time frame: Post operative - acute
28 day mortality
Time frame: 28 days post surgery
Neuropathic pain score
Time frame: 3 and 6 months post surgery
Quality of Life
Time frame: 3 and 6 months
Survival
Time frame: 3 and 6 months
QST measurements
Time frame: Pre op and post op at 72hrs and 3 months
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 5 Nov 2024.
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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.
Sibtain Anwar, MA MB FRCA study director
Barts and The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Ketamine infusion in people with Pain and Hyperalgesia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 11 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 5 Nov 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
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 Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs. (time frame: 3 and 6 months post sternotomy). 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 5 Nov 2024.