Orthopedic Disorder of Spine, Surgical Wound
Conditions
Brief summary
Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol
Detailed description
Subcutaneous local wound injections with NaCl, Ropivacain or Levobupivacaine combined with Tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. Pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery
Interventions
Local wound infiltration at the end of spine surgery with NaCl
DRUGInfiltration with Ropivacain
Local wound infiltration at the end of spine surgery with Ropivacain
DRUGInfiltration with a combination of Levobupivacaine and Tramadol
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Intervention model description
randomized, double blind, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Age ≥ 18 years * Elective spine surgery with any technique * At least 6 weeks of scheduled follow-up from hospitalization
Exclusion criteria
* Documented decline for data inclusion * Allergy to any of the drugs used * \<50kg total body weight * Vertebro- or Kyphoplasty * Pregnancy and breast feeding * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain control | 2 hours after surgery | pain assessment by visual analog with 0 = no pain and 10 = maximal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sick leave | at 42 days after surgery | duration of sick leave |
| hospital stay | up to 8 weeks | length of hospital stay in days |
| costs | at 42 days after surgery | total costs for the intervention under study in Swiss Francs |
| wound length | up to 8 weeks | wound length |
| wound healing | until 42 days after surgery | have wound healing problems occurred (yes / no) |
| wound drying | up to 8 weeks | time in days until wound is dry |
Countries
Switzerland
Outcome results
None listed