Local Wound Anesthesia in Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-03-31

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

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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

Conditions

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Surgical Wound Orthopedic Disorder of Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double blind, controlled

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Control

local wound infiltration at the end of spine surgery with NaCl

Group Type PLACEBO_COMPARATOR

Infiltration with NaCl

Intervention Type DRUG

Local wound infiltration at the end of spine surgery with NaCl

Arm I

local wound infiltration at the end of spine surgery with Ropivacain

Group Type ACTIVE_COMPARATOR

Infiltration with Ropivacain

Intervention Type DRUG

Local wound infiltration at the end of spine surgery with Ropivacain

Arm II

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

Group Type ACTIVE_COMPARATOR

Infiltration with a combination of Levobupivacaine and Tramadol

Intervention Type DRUG

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

Interventions

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Infiltration with NaCl

Local wound infiltration at the end of spine surgery with NaCl

Intervention Type DRUG

Infiltration with Ropivacain

Local wound infiltration at the end of spine surgery with Ropivacain

Intervention Type 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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No