Preventing Pain After Heart Surgery

Barts & The London NHS Trust

Status and phase: Completed; Phase 4

Conditions: Chronic Illness; Hyperalgesia; Neuropathic Pain; Pain

Treatments: Drug: Placebo capsules; Drug: Placebo infusion; Drug: Pregabalin; Drug: Ketamine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01480765

Reda 007583

2010-024462-21 (Registry Identifier)

11/H0703/7 (Registry Identifier)

Details and patient eligibility

About

The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent
• First time sternotomy for all cardiac surgery
• Patient aged 18 - 80 years

Exclusion criteria

• Emergency surgery (decision to operate taken on the day of surgery)
• Previous sternotomy
• Preoperative renal failure (eGFR <60 ml/min)
• History of chronic non-anginal pain
• Chronic pain medication other than paracetamol and non-steroidal anti-inflammatory drugs
• Concurrent use of oxycodone, lorazepam, or ethanol.
• Concurrent use of any drugs for neuropathic pain e.g. antiepileptics, antidepressants
• Allergy to pregabalin, gabapentin or ketamine
• Pregnancy
• Limited understanding of numerical scoring scales
• Previous participation in other trials investigating analgesic agents or any IMP in previous three months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Control: Placebo + Placebo

Placebo Comparator group

Description:

Placebo capsules and Placebo infusion

Treatment:

Drug: Placebo infusion

Drug: Placebo capsules

Pregabalin and Placebo infusion

Active Comparator group

Description:

Pregabalin capsules and Placebo infusion

Treatment:

Drug: Pregabalin

Drug: Placebo infusion

Pregabalin + Ketamine infusion

Active Comparator group

Description:

Pregabalin capsules + Ketamine infusion

Treatment:

Drug: Ketamine infusion

Drug: Pregabalin