Local Wound Anesthesia in Spine Surgery

Balgrist University Hospital

Status: Completed

Conditions: Surgical Wound; Orthopedic Disorder of Spine

Treatments: Drug: Infiltration with Ropivacain; Drug: Infiltration with a combination of Levobupivacaine and Tramadol; Drug: Infiltration with NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT05693454

LAWS

Details and patient eligibility

About

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

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

local wound infiltration at the end of spine surgery with NaCl

Treatment:

Drug: Infiltration with NaCl

Arm I

Active Comparator group

Description:

local wound infiltration at the end of spine surgery with Ropivacain

Treatment:

Drug: Infiltration with Ropivacain

Arm II

Active Comparator group

Description:

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

Treatment:

Drug: Infiltration with a combination of Levobupivacaine and Tramadol