Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Imperial College Healthcare NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01296347
First received: January 31, 2011
Last updated: February 14, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Chronic Postoperative Pain
Drug: Ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomised Placebo-controlled Trial to Determine Whether Low-dose Intravenous Ketamine Peri-operatively Can Prevent Chronic Post-surgical Pain, in Patients Undergoing Thoracotomy or Video Assisted Thoracic Surgery (VATS)

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • The incidence of pain [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

    Measures in pain include:

    Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine' Brief Pain Inventory (BPI) Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)



Secondary Outcome Measures:
  • Analgesic consumption [ Time Frame: 24 hours, 48 hours, 6 weeks, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Analgesia consumption will be measured post-operatively and at the time points stated above. The cumulative dose of opioid, measured in oral morphine equivalents, will be obtained from the time of the patient's arrival in recovery (T0), to 24 hours post-operatively (T0 + 24) and to 48 hours post-operatively (T0 + 48). Analgesia consumption will also be measured at six weeks, three months, six months and one year. All analgesia will be converted to oral morphine equivalents (in mg) by multiplication by a factor depending on the analgesia taken (codeine 0.15, tramadol 0.17, oxycodone 2)

  • Sensory testing [ Time Frame: 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]

    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.


  • Incidence of side-effects [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: No ]
    The presence of nausea, vomiting, itching, sedation, feeling lightheaded or vivid dreams will be recorded at the above time points

  • Incidence of pain [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

    Measures in pain include:

    Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine' Brief Pain Inventory (BPI) Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)



Estimated Enrollment: 144
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saline
Patients will receive a placebo infusion of saline, which will start 10 minutes prior to the start of the operation and 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
Other Name: Ketalar

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients (18 years and above) who are undergoing either thoracotomy or video assisted thoracic surgery (VATS).
  • Participants must be able to understand English.

Exclusion Criteria:

  • Patient refusal
  • History of previous chronic thoracic pain
  • Neuropathic pain (whatever the site), existing at time of recruitment
  • Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine.
  • Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296347

Contacts
Contact: Gillian M Chumbley, BSc, PhD 02033111000 ext 5865 gillian.chumbley@imperial.nhs.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Not yet recruiting
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Gillian M Chumbley, BSc, PhD Imperial Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Dr Gillian Chumbley, Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01296347     History of Changes
Other Study ID Numbers: Chumbley1
Study First Received: January 31, 2011
Last Updated: February 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College Healthcare NHS Trust:
Ketamine
Thoracotomy
VATS
Pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 22, 2014