Local Wound Anesthesia in Spine Surgery

Not Applicable

Completed

• Conditions: Surgical Wound; Orthopedic Disorder of Spine
• Interventions: Drug: Infiltration with NaCl; Drug: Infiltration with Ropivacain; Drug: Infiltration with a combination of Levobupivacaine and Tramadol

• Registration Number: NCT05693454
• Lead Sponsor: Balgrist University Hospital

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

Study Timeline

• Study First Submitted: 2021-07-20
• Study Start: 2021-11-01
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-23
• Primary Completion: 2023-01-31
• Study Completion: 2023-03-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Infiltration with NaCl	local wound infiltration at the end of spine surgery with NaCl
Arm I	Infiltration with Ropivacain	local wound infiltration at the end of spine surgery with Ropivacain
Arm II	Infiltration with a combination of Levobupivacaine and Tramadol	local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol

Primary Outcome Measures

Name	Time	Method
Pain control	until 42 days after surgery	analgesics consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland