Post Laparotomy Pain Treatment
Conditions
Keywords
morphine, fentanyl, methadone, epidural, intravenous, pain, analgesia
Brief summary
The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.
Interventions
DRUGintravenous morphine via PCA
DRUGepidural morphine via PCEA
DRUGepidural fentanyl via PCEA
DRUGepidural methadone via PCEA
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
\* Elective laparotomy
Exclusion criteria
* Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception * Illicit drug abusers * Chronic use of pain medication * Inability to understand consent form * Age \< 18 * Renal failure (Clcr\<50 ml/min) * Chronic use of drugs that can alter plasma levels and\\or effect of the study drugs * Corrected Q-T interval(QTc)=450msc and above * Contra-indication for epidural catheter insertion * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline | 72 hours post operatively |
| Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline. | 72 hours post operatively |
| patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline | 72 hours post operatively |
Secondary
| Measure | Time frame |
|---|---|
| Nasal capnography at rest as compared to baseline | Baseline and twice daily for 72 hours starting 18-24 hours post surgery |
| Measurement of opioid concentration in plasma as compared to baseline | Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery |
| Report of pain severity- at rest, cough and deep breathing as compared to baseline | Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery |
| Report of adverse effects' severity as compared to baseline | Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery |
| Pupillometry as compared to baseline | Baseline and twice daily for 72 hours starting 18-24 hours post surgery |
| Respiratory rate as compared to baseline | Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery |
Countries
Israel
Outcome results
None listed