Laceration, Pain, Acute
Conditions
Keywords
Laceration, Suture, Topical anesthesia, Lidocaine
Brief summary
The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.
Detailed description
A prospective randomized open clinical trial conducted in two high volume emergency departments in France. Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method. 126 patients are expected to enrol in the study.
Interventions
Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture
DRUGLidocaine 1% Epinephrine 0.005mg/mL solution
Local anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound
Sponsors
University Hospital, Angers
Centre Hospitalier le Mans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Superficial skin laceration requiring a suture
Exclusion criteria
* Known allergy to lidocaine * Mucous membrane or eye wound * Nose, ear or perineal wound * Active hemorrhage in the wound * Dirty or infected wound * Wound requiring operation room management * Distracting pain in an other location * Intoxicated or comatose patient * Patient Under guardianship * Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia * Neurologic disorder affecting pain sensitivity * Dementia * Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age * Absence of signed informed consent * Inclusion in an other interventional clinical protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain | 60 minutes | Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Topical anesthesia failure rate | 60 minutes | Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine |
| Pain management during the various stages of care | 60 minutes | Maximum pain measured on the numerical pain scale (0-10) measured on admission to the emergency department, during the wait for laceration treatment, during the wound cleansing for the intervention group and during anesthesia for the control group, during suture. |
| Patient satisfaction | 60 minutes | Patient satisfaction relating to the pain management measured on a four point Likert scale. |
| Adverse effects | 15 days | Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management |
| Wound healing | 15 days | Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening. |
| Management duration | 60 minutes | Mean duration of management between admission to the emergency department and discharge. |
Countries
France
Outcome results
None listed