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Local Wound Anesthesia in Spine Surgery

Primary Purpose

Surgical Wound, Orthopedic Disorder of Spine

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Infiltration with NaCl
Infiltration with Ropivacain
Infiltration with a combination of Levobupivacaine and Tramadol
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgical Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control

Arm I

Arm II

Arm Description

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

Outcomes

Primary Outcome Measures

Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control
analgesics consumption

Secondary Outcome Measures

costs
total costs for the intervention under study in Swiss Francs
sick leave
duration of sick leave
hospital stay
length of hospital stay in days
wound drying
time in days until wound is dry
wound length
wound length
wound healing
have wound healing problems occurred (yes / no)

Full Information

First Posted
July 20, 2021
Last Updated
June 27, 2023
Sponsor
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05693454
Brief Title
Local Wound Anesthesia in Spine Surgery
Official Title
Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Orthopedic Disorder of Spine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double blind, controlled
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
local wound infiltration at the end of spine surgery with NaCl
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
local wound infiltration at the end of spine surgery with Ropivacain
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Intervention Type
Drug
Intervention Name(s)
Infiltration with NaCl
Intervention Description
Local wound infiltration at the end of spine surgery with NaCl
Intervention Type
Drug
Intervention Name(s)
Infiltration with Ropivacain
Intervention Description
Local wound infiltration at the end of spine surgery with Ropivacain
Intervention Type
Drug
Intervention Name(s)
Infiltration with a combination of Levobupivacaine and Tramadol
Intervention Description
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol
Primary Outcome Measure Information:
Title
Pain control
Description
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time Frame
2 hours after surgery
Title
Pain control
Description
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time Frame
4 hours after surgery
Title
Pain control
Description
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time Frame
8 hours after surgery
Title
Pain control
Description
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Time Frame
12 hours after surgery
Title
Pain control
Description
analgesics consumption
Time Frame
until 42 days after surgery
Secondary Outcome Measure Information:
Title
costs
Description
total costs for the intervention under study in Swiss Francs
Time Frame
at 42 days after surgery
Title
sick leave
Description
duration of sick leave
Time Frame
at 42 days after surgery
Title
hospital stay
Description
length of hospital stay in days
Time Frame
up to 8 weeks
Title
wound drying
Description
time in days until wound is dry
Time Frame
up to 8 weeks
Title
wound length
Description
wound length
Time Frame
up to 8 weeks
Title
wound healing
Description
have wound healing problems occurred (yes / no)
Time Frame
until 42 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazda Farshad, Prof
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers outside of our institution

Learn more about this trial

Local Wound Anesthesia in Spine Surgery

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