MedDRA version: 21.0 Level: LLT Classification code 10009951 Term: Colon cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: FENTANYL & BICAIN SPINAL
Product Name: Fentanyl
Product Code: N01AH01
Pharmaceutical Form: Infusion
INN or Proposed INN: Fentanyl
Other descriptive name: FENTANYL CITRATE
INN or Proposed
Sponsors
Oulu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All residents in Finland who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigma area • Able to provide informed written consent • Patients capable of completing questionnaires at the time of consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone • Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated INR, anticoagulation, patient refusal, etc) or TAP block (patient refusal) • Urgent or emergent surgery precluding epidural catheter placement or TAP block • Systemic Infection contraindicating epidural catheter placement or TAP block • Pregnant or suspected pregnancy • <18 years • Planned open surgery • Planned bowel stoma (protective diversion and/or permanent stoma) • Unwillingness to participate in follow up assessments • No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ;Secondary Objective: ;Primary end point(s): Compare the length of post-operative hospital stay after laparoscopic colorectal surgery between the laparoscopic guided TAP block-installation and epidural analgesia.;Timepoint(s) of evaluation of this end point: Time of discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare overall operating room time, post-operative morphine milligram equivalents recruitments, visual analogue scale, and overall benefits of analgesia score, hospital readmission rates, time to first bowel movement, time to post-operative mobilization and overall cost-effectiveness ;Timepoint(s) of evaluation of this end point: Time of discharge | — |
Countries
Finland
Outcome results
None listed