Intraoperative Ketamine on Chronic Pain After Mastectomy
|ClinicalTrials.gov Identifier: NCT02729805|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : April 19, 2019
Preventive analgesia is when an administered analgesic drug provides reduction in pain beyond its duration of action. This can be used to reduce acute postoperative pain and prevent occurrence of chronic post-surgical pain.
According to the International Association for the Study of Pain (IASP), chronic pain can be defined as pain that persisted beyond the time of normal tissue healing (usually 3 months) and that was not related to other causes. Mastectomy is associated with a high incidence of chronic post-surgical pain. Breast cancer is the most common malignancy affecting females around the world. Many undergo mastectomy as part of curative treatment. However, a significant proportion of patients experience chronic post-surgical pain. This results in significant negative impact on physical, psychological and social wellbeing.
Ketamine is an intravenous anaesthetic drug with analgesic effects. It can be used to treat both acute and chronic pain. A recent meta-analysis of different surgeries showed that patients receiving ketamine had a modest but statistically significant reduction in incidence of chronic post-surgical pain. In a small sample single dose pilot study, patients given low dose intravenous ketamine intraoperatively had a statistically non-significant reduction in incidence of pain around the surgical scar at three months after radical mastectomy. Randomized control trials with larger sample sizes are needed to determine the effectiveness and optimal dosing regime of ketamine for reduction of chronic post-mastectomy pain. It is therefore hypothesized that intravenous ketamine given intraoperatively will reduce the incidence and severity of chronic pain after modified radical mastectomy. A double blind randomized controlled trial comparing placebo group with two different doses of ketamine is proposed.
The mechanism of action of ketamine in reducing pain is complex and multiple. How ketamine can prevent and reduce chronic pain is unknown. Ketamine has been shown to reduce immediate gene expression at site of mechanical injury. Transient Receptor Potential Vanilloid 1 (TRPV1) and Transient Receptor Ankyrin 1 (TRPA1) are receptors shown to mediate acute and chronic pain. Ketamine, shown to affect gene expression, may alter the expression of TRPV1 and TRPA1 via epigenetic mechanisms.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Saline Drug: Ketamine 0.5mg/kg Drug: Ketamine 0.75mg/kg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Intraoperative Intravenous Ketamine on Chronic Pain After Mastectomy|
|Actual Study Start Date :||August 18, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Placebo Comparator: Saline
A syringe of 50 ml 0.9% normal saline will be prepared as placebo for infusion and a syringe of 10ml 0.9% normal saline for bolus injection.
10ml bolus injection of saline followed by intravenous infusion of saline during the operation
Other Name: Control group
Active Comparator: Ketamine 0.5mg/kg
A bolus injection of intravenous ketamine at a dose of 0.5mg/kg during anaesthetic induction before skin incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation.
Drug: Ketamine 0.5mg/kg
0.5mg/kg intravenous ketamine injection followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
Other Name: Group K1
Experimental: Ketamine 0.75mg/kg
A bolus injection of intravenous ketamine at a dose of 0.75mg/kg during anaesthetic induction before skin incision followed by 0.5mg/kg/hr intravenous ketamine infusion during the operation.
Drug: Ketamine 0.75mg/kg
0.75mg/kg intravenous ketamine injection followed by 0.5mg/kg/hr intravenous ketamine infusion during the operation
Other Name: Group K2
- Severity of chronic pain [ Time Frame: At postoperative 3 months ]Determine the severity using numerical rating scale
- Incidence of neuropathic pain [ Time Frame: At postoperative 3 months ]Determine the incidence of neuropathic pain using Identification Pain Questionnaire for Neuropathic Pain (ID-NeP)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729805
|The University of Hong Kong|
|Hong Kong, Hong Kong, 0000|
|Principal Investigator:||Stanley SC Wong, MBBS||The University of Hong Kong|