aparoskopia avusteinen vatsanpeitteiden johtopuudutus versus epiduraali puudutus leikkauksen jälkeisessä kivun hoidossa.
- Conditions
- MedDRA version: 21.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864
- Registration Number
- EUCTR2021-004628-14-FI
- Lead Sponsor
- Oulu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 206
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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