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Intraoperative Ketamine on Chronic Pain After Mastectomy

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ClinicalTrials.gov Identifier: NCT02729805
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Wong Sau Ching Stanley, The University of Hong Kong

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
Drug: Saline
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




Primary Outcome Measures :
  1. Severity of chronic pain [ Time Frame: At postoperative 3 months ]
    Determine the severity using numerical rating scale


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the American Society of Anesthesiologists adopted physical status classification system (ASA) I-III
  • Age 18-80 years old
  • Scheduled for 1) modified radical mastectomy (including axillary lymph node dissection) and 2) mastectomy with sentinel lymph node (without axillary dissection). These are the common surgical treatments for breast cancer.

Exclusion Criteria:

  • Radical mastectomy, wide local excision or lumpectomy
  • Known allergy to opioids, local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
  • History of chronic pain
  • Alcohol or drug abuse
  • Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
  • Pre-existing neurological or muscular disorders
  • Psychiatric illness
  • Impaired or retarded mental state
  • Not self ambulatory before operation
  • Difficulties in using patient controlled analgesia (PCA)
  • Pregnancy
  • Local infection
  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729805


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Stanley SC Wong, MBBS The University of Hong Kong
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Responsible Party: Wong Sau Ching Stanley, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02729805    
Other Study ID Numbers: UW15-079
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wong Sau Ching Stanley, The University of Hong Kong:
ketamine
chronic pain
mastectomy
acute pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action