Pregabalin for acute pain in degenerative spinal surgery V 2.0

• Research type

  Research Study

• Full title

  The effect of Pregabalin in postoperative pain control after multi-level degenerative spinal surgery: A randomized controlled study

• IRAS ID

  3760

• Sponsor organisation

  The Royal Orthopaedic Hospital NHS Trust

• Eudract number

  2008-006187-11

• ISRCTN Number

  TO BE CONFIRMED

• Research summary

  This trial tests whether a drug called Ó?Pregabalin? improves pain relief after back operations in adults, reducing the amount of other pain killers used.Operations involving the spine are painful. Treatment for the pain is an epidural (injection in the spine) and morphine given by drip.Morphine is a good pain killer but has side effects such sickness, dizziness and may make you more likely to get a chest infection.Pregabalin is licensed for treating long term pain and epilepsy. It has been used in a handful of clinical trials for treating post-operation pain with some success.Consented participants will be chosen randomly to have either Pregabalin or a placebo medicine. The tablets will appear identical to avoid biasing any results.All patients will receive an epidural and morphine drip as normal. A researcher will record side effects, how bad the pain is and how much morphine is needed each day for 3 days. Results will be analysed to see if there is a difference between those who took Pregabalin and those who did not.Pregabalin side effects may include; dry mouth, constipation, nausea, vomiting, flatulence; swelling; dizziness, drowsiness, irritability, movement problems, memory impairment, excitement, confusion, appetite changes, weight gain/loss, problems with vision and sexual function; Uncommonly; abdominal distension, salivation, heartburn, taste disturbance, hofluhes, fast heart rate, feinting, shortness of breath, chest tightness, personality changes including depression, hallucinations, agitation, mood swings and panic attacks, odd sensations, speech disorder, pain in passing water/incontinence, disorders of blood clotting, joint swelling, muscle/joint pain, sweating, and rash; Rarely; painful swallowing, pancreatitis, low/high blood pressure, abnormal heartbeat, cough, nose bleeds, disorders of smell, fever, abnormal blood sugars, kidney failure, problems with periods, breast pain/discharge, low/high white blood cells, muscle breakdown, abnormal hearing, low body salts.These are usually reversible on stopping the drug.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/58

• Date of REC Opinion

  28 Apr 2009

• REC opinion

  Further Information Favourable Opinion