Local Wound Anesthesia in Spine Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial

Conditions
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Surgical Wound, Orthopedic Disorder of Spine

Intervention / Treatment
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* Drug: Infiltration with NaCl
* Drug: Infiltration with Ropivacain
* Drug: Infiltration with a combination of Levobupivacaine and Tramadol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double blind, controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>local wound infiltration at the end of spine surgery with NaCl | Drug: Infiltration with NaCl<br>* Local wound infiltration at the end of spine surgery with NaCl<br>|
| Active Comparator: Arm I<br>local wound infiltration at the end of spine surgery with Ropivacain | Drug: Infiltration with Ropivacain<br>* Local wound infiltration at the end of spine surgery with Ropivacain<br>|
| Active Comparator: Arm II<br>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<br>* Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |