Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Pain control
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
double blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Arm II
local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Intervention: Infiltration with a combination of Levobupivacaine and Tramadol (Drug)
Control
local wound infiltration at the end of spine surgery with NaCl
Intervention: Infiltration with NaCl (Drug)
Arm I
local wound infiltration at the end of spine surgery with Ropivacain
Intervention: Infiltration with Ropivacain (Drug)
Outcomes
Primary Outcomes
Pain control
Time Frame: until 42 days after surgery
analgesics consumption
Secondary Outcomes
- costs(at 42 days after surgery)
- wound healing(until 42 days after surgery)
- sick leave(at 42 days after surgery)
- wound drying(up to 8 weeks)
- hospital stay(up to 8 weeks)
- wound length(up to 8 weeks)