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). - RCT of ketamine versus placebo after thoracotomy or VATS surgery (1)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000506-21-GB

Enrollment

144

Registered

2011-04-14

Start date

2011-06-21

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic post-surgical pain

Interventions

Trade Name: Ketalar Product Name: Ketamine/ketalar Pharmaceutical Form: INN or Proposed INN: Ketamine Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All adult patients (> 18 years) who are undergoing either thoracotomy or VATS. 2. Participants must be able to understand English. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. History of previous chronic thoracic pain 3. Neuropathic pain (whatever the site), existing at time of recruitment 4. Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine. 5. Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of this research is to question whether a low-dose ketamine infusion given for 96 hours during and after surgery, will reduce the incidence of chronic post-surgical pain, 6 weeks after surgery, in patients undergoing thoracotomy and video assisted thoracic surgery (VATS).;Secondary Objective: In addition patients will be interviewed at 3 months, 6 months and one year after surgery, to establish the incidence of chronic post-surgical pain at these time periods. Data will be collected about the amount of opioid (morphine type pain killer) used after surgery to see if this is altered by an infusion of low dose ketamine. The incidence of side-effects will be established.;Primary end point(s): The primary outcome measure will be the difference in pain between the ketamine as placebo groups at 6 weeks following surgery. Pain will be measured using a numeric pain score (NPS), the brief pain inventory (BPI) and the short form Lanss (S-Lanss).	—

Measure

Time frame

Main Objective: The primary aim of this research is to question whether a low-dose ketamine infusion given for 96 hours during and after surgery, will reduce the incidence of chronic post-surgical pain, 6 weeks after surgery, in patients undergoing thoracotomy and video assisted thoracic surgery (VATS).;Secondary Objective: In addition patients will be interviewed at 3 months, 6 months and one year after surgery, to establish the incidence of chronic post-surgical pain at these time periods. Data will be collected about the amount of opioid (morphine type pain killer) used after surgery to see if this is altered by an infusion of low dose ketamine. The incidence of side-effects will be established.;Primary end point(s): The primary outcome measure will be the difference in pain between the ketamine as placebo groups at 6 weeks following surgery. Pain will be measured using a numeric pain score (NPS), the brief pain inventory (BPI) and the short form Lanss (S-Lanss).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026