ISRCTN75659782.
Trial name or title | Intra‐ and post‐operative analgesia for patients undergoing surgery for hip fracture ‐ role of fascia iliaca compartment block |
Methods | RCT Double‐blind (participants and caregivers) Funding: governmental: Department of Health, Richmond House, 79 Whitehall, London, SW1A 2NL, United Kingdom +44 (0)20 7307 2622; dhmail@doh.gsi.org.uk, http://www.dh.gov.uk/Home/fs/en |
Participants | 40 adult participants of ASA I‐III admitted to Selly Oak Hospital with hip fracture and scheduled for fixation will be recruited after consent is obtained inclusion criteria: scheduled for hip fracture surgery Exclusion criteria: dementia/confusion, preoperative chest infection and/or poor respiratory function, temperature ≥ 38°C, white cell count > 11,000 mm3, respiratory rate > 25 per minute, auscultation and/or chest x‐ray evidence, SpO2 < 90% on air, congestive cardiac failure, bed‐bound or use of ≥ 2 aids for mobilization pre‐fracture, malignancy, coagulopathy, known or suspected allergy to ropivacaine and/or morphine, local infection at site where the block is to be performed, refusal of permission to approach general practitioner |
Interventions |
Treatment group: fascia iliaca compartment block (n = 20) Control group: morphine (n = 20) Each participant will have a standard preoperative assessment, standard monitoring and recovery care and will be given assessments at 1, 3, 6 and 24 hours postop. Thereafter, data will be collected on a daily basis until 30 days postop/discharge/death, whichever is earlier. Our hospital already has a framework for data collection (Integrated Care Pathway). For our study, we will be using the same data |
Outcomes | Primary outcome measures: total dose of morphine required during first 24 hours post‐op Secondary outcome measures: time to first dose of morphine postop, pain scores in recovery room and at 13, 16 and 24 hours after surgery, time to first appropriate response to verbal commands, time to discharge from recovery room, occurrence of nausea and vomiting in recovery and number of episodes during the first 24 hours postop, total dose of cyclizine required in the first 24 hours, need for granisetron during the first 24 hours, sedation scores at 1, 3, 6 and 24 hours, mental test scores at 1, 3, 6 and 24 hours, complications, rehabilitation outcomes, mortality |
Starting date | 04/04/2006 |
Contact information | Dr FA Levins, Anaesthetics, Selly Oak Hospital, Birmingham, B29 6JD, United Kingdom |
Notes | DOI 10.1186 Protocol/serial number: N0265178818 Completed |