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Clinical trial

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

ID
Name
LAWS
Description
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
Trial arms
Trial start
2021-11-01
Estimated PCD
2023-01-31
Trial end
2023-03-31
Status
Completed
Treatment
Infiltration with NaCl
Local wound infiltration at the end of spine surgery with NaCl
Arms:
Control
Infiltration with Ropivacain
Local wound infiltration at the end of spine surgery with Ropivacain
Arms:
Arm I
Infiltration with a combination of Levobupivacaine and Tramadol
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Arms:
Arm II
Size
150
Primary endpoint
Pain control
2 hours after surgery
Pain control
4 hours after surgery
Pain control
8 hours after surgery
Pain control
12 hours after surgery
Pain control
until 42 days after surgery
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, double blind, controlled', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-06-28

1 organization

3 products

2 indications

Organization
Balgrist University Hospital
Product
NaCl
Indication
Wound Infection
Indication
Orthopedic Disorder of Spine
Product
Ropivacain
Product
Levobupivacaine + Tramadol