Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

NCT ID: NCT01527812

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-02-29

Brief Summary

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

Detailed Description

Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone.

Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5).

Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).

Conditions

Fractured Neck of Femur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Above the femoral nerve

In Group I we will inject the local anaesthetic below the fascia iliaca and above the femoral nerve.

Group Type: EXPERIMENTAL

Femoral nerve block

Intervention Type: PROCEDURE

We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.

Below the femoral nerve

In Group II we will inject the local anaesthetic below the femoral nerve and above the fascia of the iliopsoas muscle.

Group Type: EXPERIMENTAL

Femoral nerve block

Intervention Type: PROCEDURE

We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.

Circumferential

In Group III a circumferential spread will be achieved with multiple injections.

Group Type: EXPERIMENTAL

Femoral nerve block

Intervention Type: PROCEDURE

We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.

Interventions

Femoral nerve block

We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Fractured neck of femur surgical fixation performed under spinal anaesthesia
• ASA I to III

Exclusion Criteria

• Patient refusal
• Coagulation disorders
• Head injury or other associated injuries
• Previous vascular surgery in the femoral area.
• Loss of consciousness and signs of acute coronary syndrome
• Mini-Mental Score < 25 (see appendix 3)
• Allergy to lignocaine,
• Skin lesions/infection at site of injection
• Sepsis

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Szilard Szucs

Clinical Tutor in Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Szilard Szucs, MD

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital, Ireland

Locations

Cork University Hospital

Cork, Cork, Ireland

Countries

Ireland

References

Szucs S, Morau D, Sultan SF, Iohom G, Shorten G. A comparison of three techniques (local anesthetic deposited circumferential to vs. above vs. below the nerve) for ultrasound guided femoral nerve block. BMC Anesthesiol. 2014 Jan 25;14:6. doi: 10.1186/1471-2253-14-6.

Reference Type: DERIVED

PMID: 24460975 (View on PubMed)

Other Identifiers

ECM 4 (zz) 08/12/09

Identifier Type: OTHER

Identifier Source: secondary_id

ECM 4 (zz) 08/12/09

Identifier Type: -

Identifier Source: org_study_id