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ID
Source
Brief title
Health condition
postoperative pain after colorectal surgery
epidural analgesia
peripheral nerve block
abdominal wall block
pijn na darmoperatie
epiduraal
zenuwblokkade
buikwand blokkade
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome objective of this trial will be length of stay in the hospital after surgery
Secondary outcome
intra- and postoperative opioid consumption
NRS pain scores
time in the post anesthetic care unit
time to mobilize to a sitting position in a chair
catheter dislocation
development of prolonged postoperative ileus
duration of bladder catheterization
overall patient satisfaction
Background summary
Rationale: Optimal recovery after colorectal surgery is also the main goal of all ERAS (early recovery after surgery) guidelines.
To fulfill the guideline and achieve this goal, a multidisciplinary approach of treatment is state of the art. An even more important point is: to create the possibility for all patients to start their postoperative adjuvant treatment as soon as possible after surgery. To reach this goal it is necessary to discharge the patients at the earliest possible after surgery, in the best possible condition.
The actual ERAS statement regarding intra- and postoperative analgesia recommends to not use thoracic epidural catheters in laparoscopic surgery anymore as a gold standard. This study will investigate an alternative possibility of pain therapy: delivering local anesthetic via a multi hole catheter to both sites of most surgical trauma - intra-abdominal as-well as preperitoneal.
Objective: The primary outcome objective of this trial will be length of stay in the hospital after surgery. Secondary outcome measures will be intra- and postoperative opioid consumption, NRS pain scores, time in the post anesthetic care unit, time to mobilize to a sitting position in a chair, catheter dislocation, development of prolonged postoperative ileus duration of bladder catheterization and overall patient satisfaction.
Study design: The study will be designed as a prospective cohort study. We will include 22 patients per cohort.
Study population: The study population will be drawn from al adult patients being eligible for right or left sided hemicolectomy, sigmoidectomy or low anterior rectum resection and matching the below named inclusion criteria. Both, benign and malign lesions will be included.
Intervention: The control group (cohort 1) will receive the standard treatment regimen with a thoracic epidural catheter (Ropivacaine 0,2% and Sufentanil 1mcg/ml). Depending on the type of surgery the epidural catheter will be used until POD 2 (hemicolectomy) or POD 3 (low anterior rectum resection). This resembles the hospital’s standard procedure.
The treatment group (cohort 2) will receive an intravenous Lidocaine 1% during the surgical procedure. At the end of surgery the surgeon will place two OnQ silver soaker multi hole catheters. Both catheters will be primed with a bolus of Ropivacaine 0,375% 10ml each and be then connected to an elastomeric pump (OnQ) filled with Ropivacaine 0,2% and will be used for 48 hours.
Main study parameter: length of stay in days
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking into account the result of a study on laparoscopic surgery in gynecology we expect to see comparable little opioid use postoperatively, faster recovery with mobilization soon after surgery and a shorter length of stay in the interventional group.
Version number: 2.0 07-12-2018 !8 of 2! 9
These patients will be able to start their postoperative adjuvant treatment as soon as possible after surgery. To reach this goal it is necessary to discharge the patients at the earliest possible after surgery, in the best possible condition. With the standard care, an highly invasive procedure, the thoracic epidural we see a length of stay of about 6 days. With the less invasive intervention under investigation here we expect to see a shorter length of stay.
Study objective
The actual ERAS statement regarding intra- and postoperative analgesia recommends to not use thoracic epidural catheters in laparoscopic surgery anymore as a gold standard. This cohort study will investigate an alternative possibility of pain therapy: delivering local anesthetic via a multi hole catheter to both sites of most surgical trauma - intra-abdominal as-well as preperitoneal.
Taking into account the result of a study on laparoscopic surgery in gynaecology we expect to see comparable little opioid use postoperatively, faster recovery with mobilization soon after surgery and thereby a shorter length of stay in the interventional group.
Study design
primary outcome: measured from leaving the recovery area until discharge
Intervention
cohort 1: standard thoracic epidural
cohort 2: continuos abdominal wall block with catheter
preperitoneal and 2nd catheter intra-abdominal
Inclusion criteria
ASA 1-3
benign or malign indication for laparoscopic right/ left sided hemicolectomy, sigmoidectomy or low anterior rectum resection
> 18 years
informed consent (cohort 1 only for using outcome data, cohort 2 also for the actual intervention)
Exclusion criteria
ASA 4 or higher
chronic pain
chronic use of opioids
primary open surgery (laparotomy)
chances > 70% of conversion from laparoscopy to laparotomy (estimated by the surgeon prior to surgery)
emergency surgery
refusal of the patient or care takers
contra-indication for intravenous lidocaine
contra-indication for thoracic epidural (cohort 1)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7468 |
| NTR-old | NTR7710 |
| CCMO | NL67209.099.18 |
| OMON | NL-OMON46162 |