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Spinal Morphine in laparoscopic gastro-intestinal surgery


- candidate number20834
- NTR NumberNTR4870
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2014
- Secondary IDsNL43488.101.13 
- Public TitleSpinal Morphine in laparoscopic gastro-intestinal surgery
- Scientific TitleSpinal Morphine in laparoscopic gastro-intestinal surgery
- ACRONYMSALMON-trial
- hypothesisSpinal bupivacaine/morphine will enhance recovery after gastro-intestinal surgery, when compared with PCIA with opiates
- Healt Condition(s) or Problem(s) studiedAnalgesia, Laparoscopy
- Inclusion criteriaAdults
Elective laparoscopic gastro-intestinal surgery
- Exclusion criteriaRectal surgery
Bariatric surgery
Cholecystectomy
Kidney failure
Contra-indications for spinal anaesthesia
Post-operative ICU-admission
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-aug-2017
- Target number of participants60
- InterventionsSpinal bupivacaine 12,5 mg/morphine 300 mcg
- Primary outcomeLength of hospital stay
- Secondary outcomeSupplemental analgesia use
Time to recovery of bowel-function
Patient satisfaction
Side-effects
Surgical difficulty
Abdominal compliance
- TimepointsThe days until hospital discharge
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Koning
- CONTACT for SCIENTIFIC QUERIES M. Koning
- Sponsor/Initiator Maasstad Hospital
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThis study will compare the effects of intrathecal bupivacaine/morphine vs intravenous administration of opioids on recovery after laparoscopic gastro-intestinal surgery.
We hypothesize that intrathecal morphine will lead to a lower need of systemic opioids and thereby a quicker return of bowel-function. This could lead to lower length of hospital stay.
- Main changes (audit trail)
- RECORD29-okt-2014 - 26-nov-2014


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