An interventional study of Infiltration with NaCl and Infiltration with Ropivacain in Surgical Wound and Orthopedic Disorder of Spine, sponsored by Balgrist University Hospital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Balgrist University Hospital · Not applicable, Interventional, and Supportive care
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
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
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 150 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Balgrist University Hospital is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
local wound infiltration at the end of spine surgery with NaCl
Drug: Infiltration with NaCl
local wound infiltration at the end of spine surgery with Ropivacain
Drug: Infiltration with Ropivacain
local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Drug: Infiltration with a combination of Levobupivacaine and Tramadol
Local wound infiltration at the end of spine surgery with NaCl
Local wound infiltration at the end of spine surgery with Ropivacain
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time frame: 2 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time frame: 4 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time frame: 8 hours after surgery
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time frame: 12 hours after surgery
Pain control
analgesics consumption
Time frame: until 42 days after surgery
costs
total costs for the intervention under study in Swiss Francs
Time frame: at 42 days after surgery
sick leave
duration of sick leave
Time frame: at 42 days after surgery
hospital stay
length of hospital stay in days
Time frame: up to 8 weeks
wound drying
time in days until wound is dry
Time frame: up to 8 weeks
wound length
wound length
Time frame: up to 8 weeks
wound healing
have wound healing problems occurred (yes / no)
Time frame: until 42 days after surgery
Plan to share: No — IPD will not be shared with other researchers outside of our institution
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Balgrist University Hospital