Local Wound Anesthesia in Spine Surgery

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693454
• Other study ID #: LAWS
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Spinal Diseases
• Surgical Wound
• Wounds and Injuries

Intervention

Drug:
• Infiltration with NaCl
Local wound infiltration at the end of spine surgery with NaCl
• Infiltration with Ropivacain
Local wound infiltration at the end of spine surgery with Ropivacain
• Infiltration with a combination of Levobupivacaine and Tramadol
Local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	2 hours after surgery
Primary	Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	4 hours after surgery
Primary	Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	8 hours after surgery
Primary	Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	12 hours after surgery
Primary	Pain control	analgesics consumption	until 42 days after surgery
Secondary	costs	total costs for the intervention under study in Swiss Francs	at 42 days after surgery
Secondary	sick leave	duration of sick leave	at 42 days after surgery
Secondary	hospital stay	length of hospital stay in days	up to 8 weeks
Secondary	wound drying	time in days until wound is dry	up to 8 weeks
Secondary	wound length	wound length	up to 8 weeks
Secondary	wound healing	have wound healing problems occurred (yes / no)	until 42 days after surgery