Local Wound Anesthesia in Spine Surgery

NCT05693454 | Completed DMC

• 1 other identifier: LAWS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Wound; Orthopedic Disorder of Spine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• costs

  at 42 days after surgery

• sick leave

  at 42 days after surgery

• hospital stay

  up to 8 weeks

• wound drying

  up to 8 weeks

• wound length

  up to 8 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

local wound infiltration at the end of spine surgery with NaCl

Drug: Infiltration with NaCl

Arm I

ACTIVE COMPARATOR

local wound infiltration at the end of spine surgery with Ropivacain

Drug: Infiltration with Ropivacain

Arm II

ACTIVE COMPARATOR

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

Interventions

Infiltration with NaCl DRUG

Local wound infiltration at the end of spine surgery with NaCl

Control

Infiltration with Ropivacain DRUG

Local wound infiltration at the end of spine surgery with Ropivacain

Arm I

Infiltration with a combination of Levobupivacaine and Tramadol DRUG

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

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• Age ≥ 18 years
• Elective spine surgery with any technique
• At least 6 weeks of scheduled follow-up from hospitalization

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Mazda Farshad, Prof

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double blind, controlled

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: January 23, 2023
• Study Start: November 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)