A Dose Finding Study for Pain Relief of a Broken Hip

NCT00926666 | Unknown Phase 4 DMC

• 3 other identifiers: MW001EURACT 2009-013462-25R+D:NumberGN09AN334
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have suggested a link with effective pain relief and reduced illness and death in high risk patients. Ultrasound guided nerve blocks have been associated with an increased success rate and allow visualization of all the anatomical structures and the distribution of the local anesthetic on injection. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip is 14.3% (Bottle and Aylin 947-51). The aim of this clinical trial is to determine the effective dose of local anesthetic to provide pain relief to patients with a broken hip using ultrasound to guide needle insertion. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip was 14.3%. Patients for emergency surgical fixation or replacement of broken hip will be recruited prior to surgical fixation. All patients recruited to this study will receive standard anesthesia and surgical fixation of their broken hip. The trial can be divided into two sequential parts; the results of part A will be an amount of local anesthetic which will relieve pain of a broken hip in 95% of all patients. Part B will determine the duration of pain relief provided by the amount of local anaesthetic from part A and blood levels of local anesthetic. In parts A and B a standard pain relieving nerve block to numb the nerves supplying the hip joint will be administered using ultrasound to guide the injection of local anesthetic. The patient will then be observed for 30 minutes during which time the feeling in the upper leg and pain scores will be recorded. Patients with ineffective nerve blocks will be given immediate pain relief and withdrawn from further participation in the study. In part A the amount of local anesthetic for the next patient will be increased or decreased if the nerve block is ineffective or effective respectively. In part B the dose will be the same (calculated from the results of part A). In order to determine the duration of pain relief pain scores will be recorded hourly for up to 24 hours. Blood samples will be taken before the pain relieving nerve block and at 5, 10, 20, 30 and 60 minutes afterwards.

Conditions

Femoral Neck Fractures

Keywords

Ageing; Pain; Pharmacology; Imaging; Anaesthesiology; Musculoskeletal disease

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  24 hours after local anaesthetic nerve block

Secondary Outcomes (5)

• VAS resting acute pain scores

  10 mins, 20 mins and 30 mins after nerve block

• Blood pressure, respiratory rate, pulse and oxygen saturations

  10 mins, 20 mins and 30 mins after nerve block

• Liver function tests

  Before nerve block

• Venous blood gases

  before nerve block

• Serum levels of levobupivacaine

  At 5, 10, 20, 30 and 60 mins after nerve block

Interventions

Levobupivacaine DRUG

Dose finding study for levobupivacaine in fractured neck of femur patients. Ultrasound guided anterior psoas compartment nerve block to determine EC50 using up/Down methodology in patient before surgery to fix broken hip.

Eligibility Criteria

• Age: 35 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency proximal fractured neck of femur for surgical fixation
• Visual analogue pain score at rest of \>=5
• American Society of Anaesthesiology grading \<=4
• Able to give informed consent
• Resting visual analogue pain score of greater than 50mm on a 100mm scale before recruitment
• Patient is able to cooperate with sensory testing of lower limb function

You may not qualify if:

• Abnormal clotting screen (coagulopathy) or thrombocytopenia (\< 100,000)
• Acute mental test score of \<=7 at any time preoperatively
• Allergy to local anaesthetic
• Contra-indication to levobupivacaine
• Signs, symptoms or laboratory evidence of local infection or systemic sepsis
• No pre-existing neurological deficit (sensory or motor) affecting the lower limb
• Patient with lower limb amputations or other condition affecting sensation in lower limbs
• Patient with a history of chronic pain

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

Western Infirmary

Glasgow, Lanarkshire, G11 7AB, United Kingdom

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Pain; Musculoskeletal Diseases

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malcolm J Watson, MB chB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 4, 2009

Record last verified: 2009-08

Locations

GB (1)