Skip to main content
OpenTrials
Completed

NCT Number: NCT05693454

Local Wound Anesthesia in Spine Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Orthopedic Disorder of Spine Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital

Zurich, 8008, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infiltration with NaCl

Drug

Local wound infiltration at the end of spine surgery with NaCl

Infiltration with Ropivacain

Drug

Local wound infiltration at the end of spine surgery with Ropivacain

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

Primary outcomes

  1. Pain control

    Time frame: 2 hours after surgery

    pain assessment by visual analog with 0 = no pain and 10 = maximal pain

  2. Pain control

    Time frame: 4 hours after surgery

    pain assessment by visual analog with 0 = no pain and 10 = maximal pain

  3. Pain control

    Time frame: 8 hours after surgery

    pain assessment by visual analog with 0 = no pain and 10 = maximal pain

  4. Pain control

    Time frame: 12 hours after surgery

    pain assessment by visual analog with 0 = no pain and 10 = maximal pain

  5. Pain control

    Time frame: until 42 days after surgery

    analgesics consumption

Secondary outcomes

  1. costs

    Time frame: at 42 days after surgery

    total costs for the intervention under study in Swiss Francs

  2. sick leave

    Time frame: at 42 days after surgery

    duration of sick leave

  3. hospital stay

    Time frame: up to 8 weeks

    length of hospital stay in days

  4. wound drying

    Time frame: up to 8 weeks

    time in days until wound is dry

  5. wound length

    Time frame: up to 8 weeks

    wound length

  6. wound healing

    Time frame: until 42 days after surgery

    have wound healing problems occurred (yes / no)

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.