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RecruitingACTRN12609000350224

The effects of depth of volatile general anaesthesia, measured by bispectral index (BIS), on post-operative pain.

Sponsor

Dr Matthew Scott

Enrollment

150 participants

Start Date

Dec 1, 2009

Study Type

Interventional

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.

Summary

Recent studies have shown that the amount of general anaesthesia administered during an operation may influence pain and pain relief needed after surgery. We plan to use a brain monitor called bispectral index (BIS) to investigate a possible relationship between general anaesthesia and pain after surgery. We also plan to further investigate whether differing intensity of post-operative pain is influenced by either different genetic sensitivity to pain, or the body excreting fentanyl more quickly.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • 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.

Exclusion Criteria18

  • 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)

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Interventions

The treatment group will receive deeper planes of volatile general anaesthesia for the duration of surgery with a bispectral index (BIS) targeted at 30-40. (ie the dose of volatile general anaesthesia

The treatment group will receive deeper planes of volatile general anaesthesia for the duration of surgery with a bispectral index (BIS) targeted at 30-40. (ie the dose of volatile general anaesthesia will be titrated to the BIS)

Locations(1)

Auckland and Waikato, New Zealand

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ACTRN12609000350224