Clinical trial NCT04779580: Can a Subcostal Nerve Block Add Benefit to a Lateral Femoral Cutaneous Nerve Block for Open Hip Surgery
Official title: Optimising Analgesia for Lateral Hip Arthroplasty Incision: Can a Subcostal Nerve Block Add Benefit to a Lateral Femoral Cutaneous Nerve Block?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: Regional Anaesthesia
Hip Surgery
Lateral Femoral Cutaneous Nerve
Subcostal Nerve
Analgesia
Hip Arthroplasty
Lead sponsor: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hip Surgery is a very common form of surgery carried out across many hospitals within the UK in emergency and elective form. There is a variation between amongst surgeons with regard to the initial surgical incision required for the operation. It is fairly common practice to anaesthetise the Lateral Cutaneous Nerve of the thigh for analgesic reasons prior to the start of surgery, however due to the variation in surgical practice (and evolving surgical practices) this may not cover the entire surgical incision site. Another group of nerves termed the subcostal nerves has been described in the texts to perhaps cover the area of surgical incision along with blockade of the lateral cutaneous nerve of the thigh. On healthy volunteers the investigators plan to anaesthetise the lateral cutaneous nerve of the thigh, and the subcostal nerve on healthy participants to ascertain and map out the area of anaesthesia to see whether this could be a viable technique for analgesia for hip surgery in the future.

Detailed description: Hip replacement and hemiarthroplasty of the hip for neck of femur fracture are common orthopaedic procedures. The National Joint Registry in 2017 reported that 96.3% of hip replacements were performed using the anterolateral and posterior approach. NICE guidelines have suggested to utilise the anterolateral approach for hip fracture hemiarthroplasty due to decrease dislocation rates and thus, cost savings.

Despite these two commonly use approaches, the traditional incisions have, in the investigators experience, been modified. This is to accommodate the increasing evidence and emphasis on the acetabular components. Besides that, in hemiarthroplasty, various incisions have been described for the 'anterolateral' approach, such as direct lateral, curved posteriorly. 'Mini' and 'micro' incisions of the posterior approach has also been described all with the aim as tissue-sparing procedures, improving outcomes and length of stay.

In this study, the investigators aim to describe the 'traditionally' described posterior and anterolateral incisions to the hip by Moore and Hardinge:

1. Posterior - 5cm distally from the greater trochanter along the femoral diaphysis, curving the incision proximally 3-8cm towards the PSIS
2. Anterolateral - 3cm distally from the greater trochanter along the femoral diaphysis, continuing proximally 3-8cm along the femoral diaphysis

The cutaneous innervation for this area is largely supplied by the lateral femoral cutaneous nerve of the thigh; however some anatomical texts also describe contribution to this area from the subcostal nerve, or the lateral branches of the iliohypogastric nerve.

The lateral femoral cutaneous nerve can be readily identified using ultrasound, and has recently been categorised into 3 distinct types; the 'Sartorius', Posterior' and the 'Fan' types. The Sartorius type, accounting for roughly one-third, describes a dominant anterior branch running along the border of the Sartorius muscle, with no or few posterior branches.

The posterior type, accounting for roughly one-third, describes a strong posterior branch, equal in thickness to, or thicker than, the anterior branch running laterally and crossing the medial border of the tensor fasciae latae muscle immediately distal to the ASIS.

The fan type, accounting for roughly one-third, describes multiple nerve branches of equal thickness spreading over the anterolateral region of the proximal aspect of the thigh, crossing over the tensor fasciae latae muscle and the lateral border of the sartorius.

The lateral femoral cutaneous nerve can readily be identified using ultrasound and is readily blocked.

The subcostal nerve describes the distal continuation of the twelfth intercostal nerve.

Its lateral cutaneous branch perforates the obliquus internus and externus, descends over the iliac crest in front of the lateral cutaneous branch of the iliohypogastric, and is distributed to the skin of the front part of the gluteal region, extending as low as the greater trochanter.

The iliohypogastric nerve is usually a branch of the lumbar plexus originating from the L1 ventral ramus. Above the iliac crest, it enters the posterior part of the transversus abdominis. Between the transversus abdominis and internal oblique it divides into lateral and anterior cutaneous branches. The lateral cutaneous branch runs through the internal and external oblique above the iliac crest, a little behind the iliac branch of the T12 spinal nerve. It is distributed to the posterolateral gluteal skin. The iliohypogastric nerve usually gives communicating branches to the subcostal and ilioinguinal nerves. The iliac branch of the iliohypogastric nerve can be absent, replaced by the lateral cutaneous branch of the subcostal nerve. The iliohypogastric nerve is sometimes derived from the twelfth thoracic nerve and can also receive a root from the eleventh. Anloague and Huijbregts (2009) demonstrated the absence of the iliohypogastric nerve in 20.6% of the lumbar plexuses they investigated.

Anaesthesia for this incision can therefore only partly be achieved by a lateral femoral cutaneous nerve block; however this is not always complete for the territory of the incision, particularly if the incision is longer and extending more proximally. Due to the variation and sharing between the subcostal and iliohypogastric nerves, and their similar course, we will consider sonographically identified descending nerves to the gluteal region as a single entity, referred to as the subcostal nerve.

The Investigators have identified the subcostal nerve using ultrasound on volunteers and found it to lie above the superficial fascia directly above gluteus medius at the cranial aspect of the buttock, originating from the lateral abdominal wall musculature, where it can be tracked proximally to visualise its descent through the muscle layers of the lateral abdominal wall.

The investigators hypothesise that a lateral femoral cutaneous nerve block alone will not reliably provide cutaneous anaesthesia to the territory of our commonly observed incisions for hip arthroplasty. Our secondary hypothesis is that a blockade of the subcostal nerve will extend the cutaneous anaesthesia to reliably cover that area.

This study is to be conducted in three parts. Firstly, surgeons within the investigators department will be canvassed to mark out their likely line of incision for a routine elective primary hip arthroplasty. Pictorial evidence and variation will be gathered for overlay. Secondly, on volunteers, the lateral femoral cutaneous nerve will be identified using ultrasound in its course distal to the inguinal ligament, and the relevant type will be ascertained. The nerve will then be blocked using a short-acting local anaesthetic, and the area of numbness demarcated. Pictorial evidence will be gathered.

Thirdly, the subcostal nerve will be identified, and blocked using a short-acting local anaesthetic. The resulting area of numbness will be further demarcated, and further pictorial evidence gathered.

The relevant demarcated areas and incisions will be then be compared for analysis.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Peripheral neuropathy of any aetiology
* Diabetes mellitus
* Meralgia paraesthetica
* Previous Total Hip Arthroplasty
* Sciatica
* Spinal Stenosis
* Localised infection of the inguinal or gluteal regions
* Allergy to local anaesthetic or excipients
* Inability to identify either the lateral femoral cutaneous nerve or the subcostal nerve using ultrasound

Primary outcomes:
measure: Cutaneous area anaesthetised by lateral cutaneous nerve of thigh and subcostal nerve block using local anaesthetic
timeFrame: Duration of Study (approximately 5 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Queen Elizabeth Hospital NHS Trust
name: James Stimpson, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudin D, Manestar M, Ullrich O, Erhardt J, Grob K. The Anatomical Course of the Lateral Femoral Cutaneous Nerve with Special Attention to the Anterior Approach to the Hip Joint. J Bone Joint Surg Am. 2016 Apr 6;98(7):561-7. doi: 10.2106/JBJS.15.01022.
citation: Ray B, D'Souza AS, Kumar B, Marx C, Ghosh B, Gupta NK, Marx A. Variations in the course and microanatomical study of the lateral femoral cutaneous nerve and its clinical importance. Clin Anat. 2010 Nov;23(8):978-84. doi: 10.1002/ca.21043.
citation: Bodner G, Bernathova M, Galiano K, Putz D, Martinoli C, Felfernig M. Ultrasound of the lateral femoral cutaneous nerve: normal findings in a cadaver and in volunteers. Reg Anesth Pain Med. 2009 May-Jun;34(3):265-8. doi: 10.1097/AAP.0b013e31819a4fc6.
citation: Anloague PA, Huijbregts P. Anatomical variations of the lumbar plexus: a descriptive anatomy study with proposed clinical implications. J Man Manip Ther. 2009;17(4):e107-14. doi: 10.1179/106698109791352201.