Comparison of spinal prilocaine vs bupivacaine

• Research type

  Research Study

• Full title

  Comparison of heavy prilocaine to heavy bupivacaine in relation to spinal anaesthesia for perianal day case surgery.

• IRAS ID

  63704

• Contact name

  Kamran Khan

• Eudract number

  2010-024074-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Comparison of two medicines ( Bupivacaine & Prilocaine ) used in Spinal Anaesthesia for Patients Having Operations Involving the Anus as Day Case Procedures.Many minor general surgical procedures involving the anus / rectum are performed on patients as day case procedures, allowing the patient to go home the same day. Many of these procedures can be performed under spinal anaesthetic avoiding the risks and complications of general anaesthesia and it is common practice to use this technique. A spinal anaesthetic is an injection performed close to the spine that produces anaesthesia or numbness in the desired area of the body. We would like to see if one medicine is superior to the other. Both medicines are already in use for spinal anaesthetics. This study would involve recruiting patients having general surgical procedures as day case patients. Patients would have opportunity to read the information leaflet explaining everything about the study to them and have time to ask any questions, after which they would then be consented for the study if they wished to enter it.Patients would be randomly assigned to receive one of the medicines in the spinal anaesthetic and followed up by an investigator unaware of which medicine was used. The follow up would involve asking questions on the day of surgery and the day after. We are aiming to collect data on adequacy of anaesthesia, post operative pain levels, time to ability to walk unaided and pass urine and subsequently the time to reach criteria to be safely discharged back home.We would then carry out statistical analysis to see if one medicine was significantly better in terms of quality of anaesthesia,quicker recovery and faster discharge home.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/66

• Date of REC Opinion

  22 Mar 2011

• REC opinion

  Further Information Favourable Opinion