To determine whether intraoperative epidural analgesia is superior to placebo in reducing wound pain in patients after decompressive lumbar spine surgery, and to determine whether opioid use in the 2 days after surgery is significantly higher in the…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pain scores (NRS)
Secondary outcome
Difference between NRS pain score in the intervention group (epidural
bupivacaine) and standard care (Intraveneous morphine). Total postoperative
opioid consumption at 48 hours postoperatively with interim measurements at 2,
4, 6 and 24 hours. Patient satisfaction (measured by EQ-5D and GSRI), hospital
stay in days, number of adverse events.
Background summary
Lumbar spine surgery is associated with a high degree of postoperative pain.
Postoperative pain is generally managed using opioids, with varying effects on
pain, and well known side-effects. The intraoperative situation, with an
exposed epidural space, allows surgeons to apply an epidural bolus of
anesthetics at the end of the surgical procedure. Case series have shown that
this is a safe and effective technique to treat pain in the immediate
postoperative phase. We hypothesize that epidural analgesia is more effective
than placebo in suppressing postoperative wound pain in open lumbar
decompressive spine surgery, and leads to reduced opioid use in the first 48
hours after surgery.
Study objective
To determine whether intraoperative epidural analgesia is superior to placebo
in reducing wound pain in patients after decompressive lumbar spine surgery,
and to determine whether opioid use in the 2 days after surgery is
significantly higher in the placebo group.
Study design
Blinded Randomized Controlled Trial (blinding for the patient, clinician,
researcher and statistician
Intervention
Intraoperative placement of epidural catheter, application of analgesic
(Bupivacaine) or placebo.
Study burden and risks
Epidural analgesia using bupivacaine 0,25%is currently standard care for
anesthesiologists worldwide. Intraoperatively applied epidural analgesia during
decompressive spine surgery has been performed by several spine surgeons
including the team in Zuyderland MC, and case series have been published1, 2.
Open spine surgery is generally perceived as a painful procedure. Pain prevents
patients to mobilize properly after surgery. This increases complication risk,
especially in elderly patients, who are becoming candidates for decompressive
spine surgery more and more often. Postoperative pain is classically treated
using opioids. Side effects including nausea and delayed recovery of bowel
function are common. The burden for patients participating in this trial is
low. Patients are asked to fill out a questionnaire (EQ-5D and GSRI) concerning
Patient Related Outcome Measurements (PROMS). As part of the study, NRS pain
scores are additionally taken at 2, 4, 6, 24 and 48 hours after surgery. There
are no extra visits to the outpatient clinic. There are no benefits in
participating in this study compared to care as usual.
Henri Dunantstraat 5
Heerlen 6419PC
NL
Henri Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
Inclusion criteria
-Indication for open interlaminar decompressive lumbar spine surgery.
-Age over 18 years.
-Psychosocially, mentally, and physically able to fully comply with this study
protocol.
-Informed consent prior to this study.
Exclusion criteria
- Intraoperative technical (5% of cases) or medical (because of a dural tear in
8% of cases) reason in which placement of epidural catheter is not feasible or
safe.
-Pre-operative opiod use
-Previous radiotherapy at the intended surgical level.
-(Progressive) motor failure and/or anal sphincter disorders which urges
instant intervention.
-Active spinal infection.
-Immature bone (ongoing growth).
-Pregnancy.
-Contra-indications for bupivacaine or other amide type local anesthetics,
anesthesia or surgery.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003590-25-NL |
| CCMO | NL71390.096.19 |
| Other | NL8030 |
| OMON | NL-OMON25260 |