Local Wound Anesthesia in Spine Surgery

Sponsor

Balgrist University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05693454

Collaborator

(none)

150

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Orthopedic Disorder of Spine	Drug: Infiltration with NaCl Drug: Infiltration with Ropivacain Drug: Infiltration with a combination of Levobupivacaine and Tramadol	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, double blind, controlledrandomized, double blind, controlled

Masking:

Double (Participant, Investigator)

Masking Description:

double blind

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control local wound infiltration at the end of spine surgery with NaCl	Drug: Infiltration with NaCl Local wound infiltration at the end of spine surgery with NaCl
Active Comparator: Arm I local wound infiltration at the end of spine surgery with Ropivacain	Drug: Infiltration with Ropivacain Local wound infiltration at the end of spine surgery with Ropivacain
Active Comparator: Arm II 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 Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol

Arm

Intervention/Treatment

Placebo Comparator: Control

local wound infiltration at the end of spine surgery with NaCl

Drug: Infiltration with NaCl

Local wound infiltration at the end of spine surgery with NaCl

Active Comparator: Arm I

local wound infiltration at the end of spine surgery with Ropivacain

Drug: Infiltration with Ropivacain

Local wound infiltration at the end of spine surgery with Ropivacain

Active Comparator: Arm II

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

Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol

Outcome Measures

Primary Outcome Measures

Pain control [2 hours after surgery]
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control [4 hours after surgery]
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control [8 hours after surgery]
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control [12 hours after surgery]
pain assessment by visual analog with 0 = no pain and 10 = maximal pain
Pain control [until 42 days after surgery]
analgesics consumption

Secondary Outcome Measures

costs [at 42 days after surgery]
total costs for the intervention under study in Swiss Francs
sick leave [at 42 days after surgery]
duration of sick leave
hospital stay [up to 8 weeks]
length of hospital stay in days
wound drying [up to 8 weeks]
time in days until wound is dry
wound length [up to 8 weeks]
wound length
wound healing [until 42 days after surgery]
have wound healing problems occurred (yes / no)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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