Analgesic efficacy of levobupivacaine administered by wet wound dressing on skin graft donor site

Analgesic efficacy of levobupivacaine administered by wet wound dressing for the management split-thickness skin graft donor sites - HIDROGEL-014

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000232-15-ES

Enrollment

Unknown

Registered

2016-07-15

Start date

2016-07-13

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute postoperative pain

Interventions

Trade Name: CHIROCANE 7,5 mg/ml SOLUCION INYECTABLE Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: LEVOBUPIVACAINE CAS Number: 27262-47-1 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients> 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Rejection of the patient 2. Surgical procedure superior than 6hrs.3.Other conditions that warrant their inclusion as medically indicated: severe kidney illness (grade 3-4). severe hepatic illness (ChildPugh B and C grades), psychiatric illness), arrythmias, coagulation disorders, preganacy o lactation. 4. Allergy to NSAIDs, local anesthetics and / or opioids. 5. Alcoholism. 6. Abuse drugs. 7. ASA III or higher 8. When the surgery procedure time is 1 hour more from the moment of obtention of the graft

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate the analgesic efficacy of L-Bupivacaine 0.75% (max 20 ml) vs.placebo (saline) administered by wet wound dressing for the management split-thickness skin graft donor sites;Secondary Objective: 1 . Assess pain intensity at 24h by VAS. 2. Set the difference in analgesic requirements of intravenous tramadol consumption, as rescue medication, in each of the groups at 24 hours after the end of anesthesia. 3. Assess pain intensity at 72h by VAS. 4. the time until reepithelialization (up to 15 days).;Primary end point(s): Patient-reported postoperative pain, evaluated by a Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: At 6 hours from wet wound dressing is placed over donor site.	—

Measure

Time frame

Main Objective: evaluate the analgesic efficacy of L-Bupivacaine 0.75% (max 20 ml) vs.placebo (saline) administered by wet wound dressing for the management split-thickness skin graft donor sites;Secondary Objective: 1 . Assess pain intensity at 24h by VAS. 2. Set the difference in analgesic requirements of intravenous tramadol consumption, as rescue medication, in each of the groups at 24 hours after the end of anesthesia. 3. Assess pain intensity at 72h by VAS. 4. the time until reepithelialization (up to 15 days).;Primary end point(s): Patient-reported postoperative pain, evaluated by a Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: At 6 hours from wet wound dressing is placed over donor site.

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: 1.Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS). 2. Intravenous Tramadol used (mg). 3. the time until reepithelialization of donor site. Safety: 1. Adverse events and unwanted systemic and locally side effects that the patient relate and observed by investigators. 2. Other explorations carried out occasionally or symptoms that the patient relate.;Timepoint(s) of evaluation of this end point: Efficacy: 1. At 24 and 72 hours from wet wound dressing is placed over donor site, in point number 1. 2. At 24 hours, in point number 2. 3. From 7th to 15th days (every 72 hours), after surgery, in point number 3. Safety: Every study visits.	—

Measure

Time frame

Secondary end point(s): Efficacy: 1.Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS). 2. Intravenous Tramadol used (mg). 3. the time until reepithelialization of donor site. Safety: 1. Adverse events and unwanted systemic and locally side effects that the patient relate and observed by investigators. 2. Other explorations carried out occasionally or symptoms that the patient relate.;Timepoint(s) of evaluation of this end point: Efficacy: 1. At 24 and 72 hours from wet wound dressing is placed over donor site, in point number 1. 2. At 24 hours, in point number 2. 3. From 7th to 15th days (every 72 hours), after surgery, in point number 3. Safety: Every study visits.

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Countries

Spain

Contacts

Public ContactServ de Anestesia, Reanimacion

Consorcio Hospital General Universitario de Valencia .

molinervelazquez@gmail.com+34617322858

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026