A Phase 4 interventional study of Ketamine in Chronic Postoperative Pain, sponsored by Imperial College Healthcare NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.
Sponsored by Imperial College Healthcare NHS Trust · Phase 4, Interventional, and Prevention
This study will test the null hypothesis that low-dose ketamine given peri-operatively will have no effect on the development of chronic post-surgical pain, in patients undergoing thoracotomy or video assisted thoracic surgery (VATS) procedures
A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis. Potential participants due to undergo either thoracotomy or video assisted thoracic surgery (VATS) will be identified by the collaborating thoracic surgeons in the out-patient department. Patients will be sent information about the study by post, prior to admission for surgery. If they are willing to participate, written consent will be sought on the ward preoperatively, where they will complete baseline measures of pain.
Patients will be randomised to receive an intravenous infusion of placebo (saline) or ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and continuing for the first three postoperative days (96 hours in total). Prior to starting the infusion a loading dose of ketamine (0.1 mg per kg) will be administered.
This study will test the null hypothesis that low-dose ketamine given peri-operatively will have no effect on the development of chronic post-surgical pain, in patients undergoing thoracotomy or video assisted thoracic surgery (VATS) procedures
A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis. Potential participants due to undergo either thoracotomy or video assisted thoracic surgery (VATS) will be identified by the collaborating thoracic surgeons in the out-patient department. Patients will be sent information about the study by post, prior to admission for surgery. If they are willing to participate, written consent will be sought on the ward preoperatively, where they will complete baseline measures of pain.
Patients will be randomised to receive an intravenous infusion of placebo (saline) or ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and continuing for the first three postoperative days (96 hours in total). Prior to starting the infusion a loading dose of ketamine (0.1 mg per kg) will be administered. All staff, including the anaesthetist, surgical team, ward nurses and the principal investigator will be blind to the treatment given throughout the study. The key to the randomisation will be revealed at the end of the study.
Patients will be asked to complete a numeric pain score (NPS) and standard pain questionnaires which includes the Brief Pain Inventory [BPI], short form Leeds Assessment of Neuropathic Symptoms and Signs [S-LANSS]) prior to surgery, then at 6 weeks, 3, 6 and 12 months after surgery. The surgical area will also be examined at 6 weeks, 6 and 12 months for signs of neuropathic or nerve pain. Whilst in hospital patients will be asked to score their pain daily, on a numeric pain scale of 0 to 10. Consumption of morphine and side-effects will be recorded.
Patients will receive standard post-operative analgesia.
A sample size calculation based on a previous study, to detect a reduction in pain of 2 points the 10 point numeric pain scale at the 6 week assessment, with α = 5%, 1 - β = 90% and a bilateral hypothesis, would require a sample size of 36 per group, 72 patients in total. This will require a total study population of 144 patients, as both video assisted thoracic surgery (VATS) and thoracotomy patients will be studied.
A two samples t-test will be used to compare the numeric pain scores between the ketamine and placebo groups at each time point. If these data are not normally distributed then the Mann Whitney test will be used. The scores from the Brief Pain Inventory (BPI) and short form Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) will be analysed in the same manner. The Chi Squared test will be used to compare dichotomous data, such as the incidence of side-effects.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 77 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Drug: Ketamine
Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
Also known as: Ketalar
Pain Score on Moving at 6 Weeks
Measures in pain include: Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'
Time frame: 6 weeks after surgery
Analgesic Consumption (Opioid)
Analgesia consumption will be measured post-operatively and at 6 weeks
Time frame: 6 weeks, 3 month, 6 month
Sensory Testing
Hypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue. Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side. Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side. Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side.
Time frame: 6 weeks, 6 months, 12 months
Incidence of Side-effects, Nausea
The presence of nausea recorded at the above time points
Time frame: 108 hours
Incidence of Side Effect, Vomiting
The presence of vomiting recorded at the above time points
Time frame: 108 hours
Incidence of Side Effect, Lightheaded
The presence of lightheaded recorded at the above time points
Time frame: 108 hours
Incidence of Side Effect, Vivid Dreams
The presence of vivid dreams recorded at the above time points
Time frame: 108 hours
| Milestone | Saline | Ketamine |
|---|---|---|
| Started | 38 | 39 |
| Completed | 35 | 35 |
| Not completed | 3 | 4 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Lack of efficacy | 1 | 2 |
| Withdrew: Not received infusion | 1 | 0 |
| Milestone | Saline | Ketamine |
|---|---|---|
| Started | 35 | 35 |
| Completed | 35 | 34 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
| Milestone | Saline | Ketamine |
|---|---|---|
| Started | 35 | 34 |
| Completed | 34 | 33 |
| Not completed | 1 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Saline | Ketamine |
|---|---|---|
| Started | 34 | 33 |
| Completed | 32 | 31 |
| Not completed | 2 | 2 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Saline | Ketamine |
|---|---|---|
| Started | 32 | 31 |
| Completed | 28 | 28 |
| Not completed | 4 | 3 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Measures in pain include: Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'
| units on a scale | Saline | Ketamine |
|---|---|---|
| Pain Score on Moving at 6 Weeks | 0 (0 to 0) | 1.5 (0 to 4) |
Analgesia consumption will be measured post-operatively and at 6 weeks
| mg | Saline | Ketamine |
|---|---|---|
| 6 weeks | 9 (0 to 26) | 0 (0 to 21) |
| 3 months | 21 (9 to 47) | 17 (17 to 17) |
| 6 months | 34 (34 to 34) | 9 (9 to 9) |
Hypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue. Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side. Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side. Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side.
Results for this outcome have not been posted.
The presence of nausea recorded at the above time points
| Participants | Saline | Ketamine |
|---|---|---|
| Incidence of Side-effects, Nausea | 14 | 17 |
The presence of vomiting recorded at the above time points
| Participants | Saline | Ketamine |
|---|---|---|
| Incidence of Side Effect, Vomiting | 8 | 8 |
The presence of lightheaded recorded at the above time points
| Participants | Saline | Ketamine |
|---|---|---|
| Incidence of Side Effect, Lightheaded | 5 | 14 |
The presence of vivid dreams recorded at the above time points
| Participants | Saline | Ketamine |
|---|---|---|
| Incidence of Side Effect, Vivid Dreams | 2 | 13 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline | 0/38 (0%) | 8/38 (21.1%) | 34/38 (89.5%) |
| Ketamine | 0/39 (0%) | 9/39 (23.1%) | 39/39 (100%) |
| Event | Saline | Ketamine |
|---|---|---|
| Respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 3/38 | 1/39 |
| Hallucination, visualEye disorders | 2/38 | 2/39 |
| cardiac arrestCardiac disorders | 1/38 | 0/39 |
| Agitation postoperativePsychiatric disorders | 1/38 | 0/39 |
| Renal failureRenal and urinary disorders | 1/38 | 0/39 |
| HypotensionCardiac disorders | 0/38 | 1/39 |
| Bronchial obstructionRespiratory, thoracic and mediastinal disorders | 0/38 | 1/39 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/38 | 1/39 |
| Lung hypoinflationRespiratory, thoracic and mediastinal disorders | 0/38 | 1/39 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/38 | 1/39 |
| Event | Saline | Ketamine |
|---|---|---|
| NauseaGastrointestinal disorders | 14/38 | 17/39 |
| DizzinessNervous system disorders | 5/38 | 14/39 |
| PruritusSkin and subcutaneous tissue disorders | 13/38 | 12/39 |
| Vivid dreamsNervous system disorders | 2/38 | 13/39 |
| VomitingGastrointestinal disorders | 8/38 | 8/39 |
| Age, Continuous(years) | Saline | Ketamine | Total |
|---|---|---|---|
| Mean | 68 (48 to 87) | 61 (26 to 77) | 64.5 (26 to 87) |
| Sex: Female, Male(Participants) | Saline | Ketamine | Total |
|---|---|---|---|
| Female | 23 | 15 | 38 |
| Male | 12 | 20 | 32 |
| Region of Enrollment(participants) | Saline | Ketamine | Total |
|---|---|---|---|
| United Kingdom | 35 | 35 | 70 |
Plan to share: No
The record gives a start of Apr 2011, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2017, 1 year 9 months after primary completion.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
Imperial College Healthcare NHS Trust