Cutaneous Anesthesia of the Lateral Femoral Cutaneous Nerve

NCT03138668 | Completed Phase 2

• 2 other identifiers: SM2-KHT-20162016-004936-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in healthy volunteers, as a blinded, randomized, paired trial.

Conditions

Nerve Block; Anesthesia, Local; Pain, Postoperative; Anatomical Distribution; Nervus Cutaneous Femoris Lateralis; Lateral Femoral Cutaneous Nerve

Outcome Measures

Primary Outcomes (1)

• Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation with an alcohol swab.

  Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by cold sensation with an alcohol swab.

  1 hour post-block

Secondary Outcomes (9)

• Difference in the percentage coverage of the incision (anterolateral approach) assessed by cold sensation with an alcohol swab.

  1 hour post-block

• Difference in the percentage coverage of the incision (posterior approach) assessed by pinprick (von frey).

  1 hour post-block

• Difference in the percentage coverage of the incision (anterolateral approach) assessed by pinprick (von frey).

  1 hour post-block

• The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach)

  1 hour post-block

• The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach)

  1 hour post-block

Study Arms (2)

Low dose Ropivacaine

EXPERIMENTAL

Perineural injection of 8 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve

Drug: Ropivacaine Injection

High dose Ropivacaine

EXPERIMENTAL

Perineural injection of 16 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve.

Drug: Ropivacaine Injection

Interventions

Ropivacaine Injection DRUG

All 20 study participants will receive both treatment "Low dose Ropivacaine" and "High dose Ropivacaine" in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment "Low dose Ropivacaine" and "High dose Ropivacaine" will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment "Low dose Ropivacaine" in the right lower extremity, treatment "High dose Ropivacaine" will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.

Also known as: 8 ml Ropivacaine 0.75%

Low dose Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant who have given their written consent after understanding the content and limitations of the study.
• ASA 1-2
• BMI ≥ 18 or ≤ 30

You may not qualify if:

• Participants who can not cooperate in the study.
• Participants who can not speak or understand danish.
• Allergies to the drugs used in the study.
• Alcohol abuse, by the investigators judgement.
• Drug abuse, by the investigators judgement.
• Daily use of prescription required analgesic drugs within the last four weeks.
• Consumption of over the counter analgesic drugs within the last 48 hours.
• Neuromuscular defects, former surgery or trauma to the lower extremities. (Hip to knee)
• Broken skin or wounds on the lower extremities, that could be hindering in the evaluation of the anatomical distribution of the LFCN block.
• Diabetes Mellitus.
• Pregnant women (women in the fertile age must be using safe contraception and produce a negative urine-HCG test to be able to participate in the study).
• Large tattoos in the examination area.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Naestved Hospital: collaborator

Study Sites (1)

Zealand University Hospital, Køge

Køge, 4600, Denmark

Location

Related Publications (17)

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

  PMID: 14667752 BACKGROUND

• Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.

  PMID: 25599296 BACKGROUND

• Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.

  PMID: 16288617 BACKGROUND

• Thybo KH, Schmidt H, Hagi-Pedersen D. Effect of lateral femoral cutaneous nerve-block on pain after total hip arthroplasty: a randomised, blinded, placebo-controlled trial. BMC Anesthesiol. 2016 Mar 23;16:21. doi: 10.1186/s12871-016-0183-4.

  PMID: 27006014 BACKGROUND

• Thybo KH, Mathiesen O, Dahl JB, Schmidt H, Hagi-Pedersen D. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomised trial. Acta Anaesthesiol Scand. 2016 Oct;60(9):1297-305. doi: 10.1111/aas.12764. Epub 2016 Jul 18.

  PMID: 27426231 BACKGROUND

• Doklamyai P, Agthong S, Chentanez V, Huanmanop T, Amarase C, Surunchupakorn P, Yotnuengnit P. Anatomy of the lateral femoral cutaneous nerve related to inguinal ligament, adjacent bony landmarks, and femoral artery. Clin Anat. 2008 Nov;21(8):769-74. doi: 10.1002/ca.20716.

  PMID: 18942079 BACKGROUND

• Surucu HS, Tanyeli E, Sargon MF, Karahan ST. An anatomic study of the lateral femoral cutaneous nerve. Surg Radiol Anat. 1997;19(5):307-10. doi: 10.1007/BF01637599.

  PMID: 9413078 BACKGROUND

• Grothaus MC, Holt M, Mekhail AO, Ebraheim NA, Yeasting RA. Lateral femoral cutaneous nerve: an anatomic study. Clin Orthop Relat Res. 2005 Aug;(437):164-8. doi: 10.1097/01.blo.0000164526.08610.97.

  PMID: 16056045 BACKGROUND

• Dimitropoulos G, Schaepkens van Riempst J, Schertenleib P. Anatomical variation of the lateral femoral cutaneous nerve: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2011 Jul;64(7):961-2. doi: 10.1016/j.bjps.2010.11.020. Epub 2011 Jan 3.

  PMID: 21208836 BACKGROUND

• Davies A, Crossley A, Harper M, O'Loughlin E. Lateral cutaneous femoral nerve blockade-limited skin incision coverage in hip arthroplasty. Anaesth Intensive Care. 2014 Sep;42(5):625-30. doi: 10.1177/0310057X1404200513.

  PMID: 25233177 BACKGROUND

• Corujo A, Franco CD, Williams JM. The sensory territory of the lateral cutaneous nerve of the thigh as determined by anatomic dissections and ultrasound-guided blocks. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):561-4. doi: 10.1097/AAP.0b013e318261c8b6.

  PMID: 22878522 BACKGROUND

• Tomaszewski KA, Popieluszko P, Henry BM, Roy J, Sanna B, Kijek MR, Walocha JA. The surgical anatomy of the lateral femoral cutaneous nerve in the inguinal region: a meta-analysis. Hernia. 2016 Oct;20(5):649-57. doi: 10.1007/s10029-016-1493-7. Epub 2016 Apr 26.

  PMID: 27115766 BACKGROUND

• 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.

  PMID: 27053584 BACKGROUND

• Hanna A. The lateral femoral cutaneous nerve canal. J Neurosurg. 2017 Mar;126(3):972-978. doi: 10.3171/2016.1.JNS152262. Epub 2016 Apr 22.

  PMID: 27104839 BACKGROUND

• Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.

  PMID: 23558369 BACKGROUND

• Vilhelmsen F, Nersesjan M, Andersen JH, Danker JK, Broeng L, Hagi-Pedersen D, Mathiesen O, Thybo KH. Lateral femoral cutaneous nerve block with different volumes of Ropivacaine: a randomized trial in healthy volunteers. BMC Anesthesiol. 2019 Aug 28;19(1):165. doi: 10.1186/s12871-019-0833-4.

  PMID: 31455249 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Daniel Hägi-Pedersen, MD, PhD

  Naestved Hospital

  STUDY CHAIR

• Kasper H Thybo, MD

  Naestved Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 19, 2017
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)