NCT02696460

Brief Summary

Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

December 8, 2015

Last Update Submit

February 25, 2016

Conditions

Chronic Leg Ulcer

Keywords

debridementanalgesia

Outcome Measures

Primary Outcomes (1)

  • Change of Pain Level as Measured by Visual Analogue Scale (VAS)

    Change of measured VAS between Time Point "Baseline", which is 1 Minute Before Start of Surgical Debridement, and Time Point "End of Surgical Debridement", which is at Maximum Wound Profoundness and up to 10 Minutes after Start of Surgical Debridement.

    Change of VAS from Time Point "Baseline 1 Minute before Start of Surgical Debridement" at Time Point "End of Surgical Debridement up to 10 Minutes after Start of Surgical Debridement"

Secondary Outcomes (5)

  • Change of Pain Level as Measured by Visual Analogue Scale (VAS)

    Change of VAS from Time Point "End of Surgical Debridement" at Time Point "5 Minutes After Surgical Debridement"

  • Overall Duration of Treatment Session

    From Admission to Discharge up to 60 Minutes

  • Duration of Wound Debridement

    From Start to End of Debridement up to 10 Minutes

  • Achievement of Treatment Goal

    From Start to End of Debridement up to 10 Minutes

  • Overall Analgesia Quality

    From Start to End of Debridement up to 10 Minutes

Study Arms (2)

N2O/O2 analgesia

ACTIVE COMPARATOR

Wound debridement under analgesia with N2O/O2 premix.

Procedure: N2O/O2 analgesiaProcedure: Lidocaine/Prilocaine analgesia

Lidocaine/Prilocaine analgesia

ACTIVE COMPARATOR

Wound debridement under analgesia with eutectic mixture of 5% lidocaine/prilocaine.

Procedure: N2O/O2 analgesiaProcedure: Lidocaine/Prilocaine analgesia

Interventions

N2O/O2 analgesiaPROCEDURE

Analgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix.

Also known as: Kalinox® analgesia
Lidocaine/Prilocaine analgesiaN2O/O2 analgesia
Lidocaine/Prilocaine analgesiaPROCEDURE

Analgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream.

Also known as: EMLA® analgesia
Lidocaine/Prilocaine analgesiaN2O/O2 analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of chronic leg ulcer persisting for more than six weeks despite initial conservative treatment; written informed consent

You may not qualify if:

  • Other chronic wounds than leg ulcers
  • Peripheral polyneuropathy
  • Non-specified peripheral sensibility disorders
  • Allergies or contraindications against the study agents
  • Lack of informed consent
  • Pregnancy or breast feeding
  • Anticipated need for less than two surgical debridement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7. doi: 10.2165/00002512-200724060-00006.

    PMID: 17571915BACKGROUND

  • Onody P, Gil P, Hennequin M. Safety of inhalation of a 50% nitrous oxide/oxygen premix: a prospective survey of 35 828 administrations. Drug Saf. 2006;29(7):633-40. doi: 10.2165/00002018-200629070-00008.

    PMID: 16808555BACKGROUND

  • Zwakhalen SM, Hamers JP, Berger MP. Improving the clinical usefulness of a behavioural pain scale for older people with dementia. J Adv Nurs. 2007 Jun;58(5):493-502. doi: 10.1111/j.1365-2648.2007.04255.x. Epub 2007 Apr 17.

    PMID: 17442027BACKGROUND

  • Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics. 2000 Apr;105(4):E47. doi: 10.1542/peds.105.4.e47.

    PMID: 10742368BACKGROUND

  • Evans E, Gray M. Do topical analgesics reduce pain associated with wound dressing changes or debridement of chronic wounds? J Wound Ostomy Continence Nurs. 2005 Sep-Oct;32(5):287-90. doi: 10.1097/00152192-200509000-00002. No abstract available.

    PMID: 16234718BACKGROUND

  • Hee HI, Goy RW, Ng AS. Effective reduction of anxiety and pain during venous cannulation in children: a comparison of analgesic efficacy conferred by nitrous oxide, EMLA and combination. Paediatr Anaesth. 2003 Mar;13(3):210-6. doi: 10.1046/j.1460-9592.2003.01051.x.

    PMID: 12641682BACKGROUND

  • Doughty DB. Strategies for minimizing chronic wound pain. Adv Skin Wound Care. 2006 Mar;19(2):82-5. doi: 10.1097/00129334-200603000-00009. No abstract available.

    PMID: 16557053BACKGROUND

  • Rosenthal D, Murphy F, Gottschalk R, Baxter M, Lycka B, Nevin K. Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. J Wound Care. 2001 Jan;10(1):503-5. doi: 10.12968/jowc.2001.10.1.26042.

    PMID: 12964231BACKGROUND

  • Holm J, Andren B, Grafford K. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Acta Derm Venereol. 1990;70(2):132-6.

    PMID: 1969197BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Juerg Traber, MD

    Venenklinik Bellevue

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Clinic Director Surgery

Study Record Dates

First Submitted

December 8, 2015

First Posted

March 2, 2016

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

March 2, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share