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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05693454
Other study ID # LAWS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date March 31, 2023

Study information

Verified date June 2023
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Infiltration with NaCl
Local wound infiltration at the end of spine surgery with NaCl
Infiltration with Ropivacain
Local wound infiltration at the end of spine surgery with Ropivacain
Infiltration with a combination of Levobupivacaine and Tramadol
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol

Locations

Country Name City State
Switzerland Balgrist University Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain control pain assessment by visual analog with 0 = no pain and 10 = maximal pain 2 hours after surgery
Primary Pain control pain assessment by visual analog with 0 = no pain and 10 = maximal pain 4 hours after surgery
Primary Pain control pain assessment by visual analog with 0 = no pain and 10 = maximal pain 8 hours after surgery
Primary Pain control pain assessment by visual analog with 0 = no pain and 10 = maximal pain 12 hours after surgery
Primary Pain control analgesics consumption until 42 days after surgery
Secondary costs total costs for the intervention under study in Swiss Francs at 42 days after surgery
Secondary sick leave duration of sick leave at 42 days after surgery
Secondary hospital stay length of hospital stay in days up to 8 weeks
Secondary wound drying time in days until wound is dry up to 8 weeks
Secondary wound length wound length up to 8 weeks
Secondary wound healing have wound healing problems occurred (yes / no) until 42 days after surgery
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