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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | local wound infiltration at the end of spine surgery with NaCl |
|
| Arm I | Active Comparator | local wound infiltration at the end of spine surgery with Ropivacain |
|
| Arm II | Active Comparator | local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiltration with NaCl | Drug | Local wound infiltration at the end of spine surgery with NaCl |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain control | pain assessment by visual analog with 0 = no pain and 10 = maximal pain | 2 hours after surgery |
| Pain control | pain assessment by visual analog with 0 = no pain and 10 = maximal pain | 4 hours after surgery |
| Pain control | pain assessment by visual analog with 0 = no pain and 10 = maximal pain | 8 hours after surgery |
| Pain control | pain assessment by visual analog with 0 = no pain and 10 = maximal pain | 12 hours after surgery |
| Pain control | analgesics consumption | until 42 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| costs | total costs for the intervention under study in Swiss Francs | at 42 days after surgery |
| sick leave | duration of sick leave | at 42 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazda Farshad, Prof | Balgrist University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | 8008 | Switzerland |
IPD will not be shared with other researchers outside of our institution
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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randomized, double blind, controlled
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double blind
| Infiltration with Ropivacain |
| Drug |
Local wound infiltration at the end of spine surgery with Ropivacain |
|
| Infiltration with a combination of Levobupivacaine and Tramadol | Drug | Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol |
|
| hospital stay | length of hospital stay in days | up to 8 weeks |
| wound drying | time in days until wound is dry | up to 8 weeks |
| wound length | wound length | up to 8 weeks |
| wound healing | have wound healing problems occurred (yes / no) | until 42 days after surgery |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |