Local Wound Anesthesia in Spine Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Orthopedic Disorder of Spine
• Intervention / Treatment: Drug: Infiltration with NaCl; Drug: Infiltration with Ropivacain; Drug: Infiltration with a combination of Levobupivacaine and 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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mazda Farshad, Prof; Phone Number: +41 44 386 11 11; Email: mazda.farshad@balgrist.ch
• Study Contact Backup: Name: Samuel Haupt, MD; Phone Number: +41 44 386 11 11; Email: samuel.haupt@balgrist.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; local wound infiltration at the end of spine surgery with NaCl	Drug: Infiltration with NaCl; Local wound infiltration at the end of spine surgery with NaCl
Active Comparator: Arm I; local wound infiltration at the end of spine surgery with Ropivacain	Drug: Infiltration with Ropivacain; Local wound infiltration at the end of spine surgery with Ropivacain
Active Comparator: Arm II; local wound infiltration at the end of spine surgery with a combination of Levobupivacaine and Tramadol	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	2 hours after surgery
Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	4 hours after surgery
Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	8 hours after surgery
Pain control	pain assessment by visual analog with 0 = no pain and 10 = maximal pain	12 hours after surgery
Pain control	analgesics consumption	until 42 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Mazda Farshad, Prof, Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Wounds and Injuries; Surgical Wound; Musculoskeletal Diseases; Spinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Tramadol; Levobupivacaine
• Other Study ID Numbers: LAWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers outside of our institution

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No