The effects of depth of volatile general anaesthesia, measured by bispectral index (BIS), on post-operative pain.
- Conditions
- Persistent post-operative pain. For the purpose of our study, persistent pain is defined as pain in the first 3-6 months after surgery.Early post-operative pain. For the purpose of our study, early post-operative pain is defined as pain in the first 24 to 48 hours after surgery.Anaesthesiology - Pain management
- Registration Number
- ACTRN12609000350224
- Lead Sponsor
- Dr Matthew Scott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Patients scheduled for elective surgery with a non-malignant diagnosis, aged 18-65 years, American Society of Anaesthesiologists score (ASA) 1 or 2, competent to consent to participation, able to use and visual analogue scale (VAS) and able to activate a patient controlled analgesia (PCA) machine post-operatively.
Emergency surgery
Age greater than 65 years
Age less than 18 years.
ASA 3 or above.
Inability to consent or lack of written consent
Inability to speak English fluently
Malignancy diagnosed or suspected pre-operatively
Epilepsy, neuromuscular disease, psychiatric illness or COPD with carbon dioxide retention
Pre-operative chronic opioid use
Morphine allergy, allergy to drugs used as part of the standardised general anaesthetic, history of malignant hyperthermia
Use of regional anaesthesia or neuraxial blockade (or request for regional anaesthesia by patient)
Use of TIVA rather than volatile general anaesthesia
Protocol broken intra-operatively (or post-operatively)
Return to theatre for re-operation within 48 hours
Pregnancy
Severe asthma
Expected duration of surgery > 3 hours (180 minutes)
Obesity (Weight > 120kg or body mass index (BMI) >35 kg/m2)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Our primary aim is to determine whether depth of volatile general anaesthesia, as measured by BIS, influences early post-operative pain scores and analgesic requirements in patients undergoing elective surgery.[Visual analogue pain score, patient controlled analgesia morphine consumption and incidence of nausea and vomiting will be assessed daily from days 0 to 2 post-operatively.]
- Secondary Outcome Measures
Name Time Method The secondary aim of our study is to assess whether depth of volatile general anaesthesia, as measured by BIS, influences persistent post-operative pain.[A functional assessment of persistent pain, analgesic requirements and limitations of activities of daily living will occur through a single telephone call at 3 months post-operatively and again at 6 months post-operatively.]