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

NCT01296347 | Completed Phase 4 Results DMC

• 1 other identifier: Chumbley1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Postoperative Pain

Keywords

Ketamine; Thoracotomy; VATS; Pain

Outcome Measures

Primary Outcomes (1)

• 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'

  6 weeks after surgery

Secondary Outcomes (6)

• Analgesic Consumption (Opioid)

  6 weeks, 3 month, 6 month

• Sensory Testing

  6 weeks, 6 months, 12 months

• Incidence of Side-effects, Nausea

  108 hours

• Incidence of Side Effect, Vomiting

  108 hours

• Incidence of Side Effect, Lightheaded

  108 hours

Study Arms (2)

Saline

NO INTERVENTION

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.

ketamine

EXPERIMENTAL

Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours

Drug: Ketamine

Interventions

Ketamine DRUG

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

ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Chumbley GM, Thompson L, Swatman JE, Urch C. Ketamine infusion for 96 hr after thoracotomy: Effects on acute and persistent pain. Eur J Pain. 2019 May;23(5):985-993. doi: 10.1002/ejp.1366. Epub 2019 Feb 4.

  PMID: 30719817 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr Gillian Chumbley
• Organization: ImperialNHSTrust

gillian.chumbley@imperial.nhs.uk

+44 203 311 1000

Study Officials

• Gillian M Chumbley, BSc, PhD

  Imperial Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nurse

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 15, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 4, 2019
• Results First Posted: April 14, 2017

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)