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Study comparing a regional leg block vs. local anaesthetic infiltration for leg donor sites in burns patients - pain scores and analgesic requirements

Study of fascia iliaca blocks vs. conventional local anaesthetic infiltrations for leg donor sites in burns patients – pain scores and analgesic requirements

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82948372
Enrollment
60
Registered
2016-05-04
Start date
2016-03-01
Completion date
Unknown
Last updated
2018-09-10

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

Conditions

Pain in the donor sites of burns patients Injury, Occupational Diseases, Poisoning

Interventions

Patients coming to the burns or plastics theatres for skin grafting and where the graft is to be taken from the thigh would be included after applying the exclusion criteria. Burn size would be less

Sponsors

Mid Essex Hospital Services NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients with burns admitted to the burns service at St. Andrews with <7% burns and undergoing split skin grafts where the donor site will be the anterolateral thigh only and expected to be at least 0.5% total body surface area (TBSA).

Exclusion criteria

Exclusion criteria: 1. Patients <16 years old 2. Patients unable to comment on the pain scores effectively e.g., unable to speak English 3. Patients unable to give informed consent e.g., dementia 4. Patients refusing consent for the fascia iliaca block 5. Patients requesting a particular form of analgesia 6. Patients previously on treatment for chronic pain conditions 7. Patients from whom multiple donor sites are anticipated 8. Patients with renal impairment sufficient to alter the planned opiate dosage 9. Patients with a current or previous history of opiate abuse

Design outcomes

Primary

MeasureTime frame
The use of opiate painkillers at 24 and 48 hours. Our chosen threshold for a clinically significant difference will be a 20% difference in opiate usage at 24 and 48 hours between patients receiving fascia iliaca blocks, compared to those receiving the same volume and concentration of local anaesthetic via direct infiltration into the skin.

Secondary

MeasureTime frame
1. Maximum pain score 6 hours after surgery, first post-operative day and second post-operative day 2. Time to first dose of opiate medication after discharge from recovery 3. Patient satisfaction with post-operative analgesia, assessed at 24 and 48 hours 4. The density and duration of muscle weakness associated with fascia iliaca blocks by the use of bromage scores in the first and second post-operative day (does not include patients who are not allowed to move the grafted leg)

Countries

United Kingdom

Contacts

Public ContactMalka Sandunmalee ;Peter Liyanage;Berry

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Outcome results

None listed

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