NCT01480765

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

December 12, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2013

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

November 24, 2011

Last Update Submit

November 4, 2024

Conditions

PainHyperalgesiaChronic IllnessNeuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.

    3 and 6 months post sternotomy

Secondary Outcomes (11)

  • Total morphine consumption at 24 hours post surgery

    24 hours post surgery

  • Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs

    24 hours post surgery

  • Sedation (including pCO2) and nausea scores at 24 hours post surgery

    24 hours post surgery

  • Side effect episodes (dizziness, confusion, blurred vision)

    First 48 hours

  • Time to extubation

    Post op recovery period

  • +6 more secondary outcomes

Study Arms (3)

Control: Placebo + Placebo

PLACEBO COMPARATOR

Placebo capsules and Placebo infusion

Drug: Placebo capsulesDrug: Placebo infusion

Pregabalin and Placebo infusion

ACTIVE COMPARATOR

Pregabalin capsules and Placebo infusion

Drug: PregabalinDrug: Placebo infusion

Pregabalin + Ketamine infusion

ACTIVE COMPARATOR

Pregabalin capsules + Ketamine infusion

Drug: PregabalinDrug: Ketamine infusion

Interventions

PregabalinDRUG

150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days

Pregabalin + Ketamine infusionPregabalin and Placebo infusion
Ketamine infusionDRUG

0.1mg/kg/hr for 48 hours post operatively

Pregabalin + Ketamine infusion
Placebo capsulesDRUG

Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days

Control: Placebo + Placebo
Placebo infusionDRUG

Normal saline placebo intravenous infusion for 48 hours

Control: Placebo + PlaceboPregabalin and Placebo infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Ananesthesia Research Centre, Barts and The London NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

PainHyperalgesiaChronic DiseaseNeuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System DiseasesDisease AttributesPathologic ProcessesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sibtain Anwar, MA MB FRCA

    Barts and The London NHS Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2011

First Posted

November 29, 2011

Study Start

December 12, 2011

Primary Completion

March 7, 2013

Study Completion

March 7, 2013

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

GB(1)