Local Wound Anesthesia in Spine Surgery

Balgrist University Hospital150 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

150

Conditions

Surgical Wound Orthopedic Disorder of Spine

Interventions

Infiltration with NaClDRUG

Local wound infiltration at the end of spine surgery with NaCl

Infiltration with RopivacainDRUG

Local wound infiltration at the end of spine surgery with Ropivacain

Infiltration with a combination of Levobupivacaine and TramadolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Balgrist University Hospital

Zurich, Switzerland

Outcomes

Primary Outcomes

Pain control

pain assessment by visual analog with 0 = no pain and 10 = maximal pain

Time frame: 2 hours after surgery

Pain control

pain assessment by visual analog with 0 = no pain and 10 = maximal pain

Time frame: 4 hours after surgery

Pain control

pain assessment by visual analog with 0 = no pain and 10 = maximal pain

Time frame: 8 hours after surgery

Pain control

pain assessment by visual analog with 0 = no pain and 10 = maximal pain

Time frame: 12 hours after surgery

Pain control

analgesics consumption

Time frame: until 42 days after surgery

Secondary Outcomes

costs

total costs for the intervention under study in Swiss Francs

Time frame: at 42 days after surgery

sick leave

duration of sick leave

Time frame: at 42 days after surgery

hospital stay

length of hospital stay in days

Time frame: up to 8 weeks

wound drying

time in days until wound is dry

Time frame: up to 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.