Sensory Distribution of Lateral Femoral Cutaneous Nerve Block

NCT02957903 | Completed Phase 4

• 2 other identifiers: SM1-KHT-20162016-002643-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be conducted in healthy volunteers in a blinded, randomized paired study.

Conditions

Nerve Block; Anesthesia, Local; Pain, Postoperative; Anatomical Distribution

Outcome Measures

Primary Outcomes (1)

• Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation

  Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.

  1 hour post-block

Secondary Outcomes (14)

• Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by cold sensation

  1 hour post-block

• Difference in the percentage coverage of the incision (posterior approach) assessed by pin-prick

  1 hour post-block

• Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by pin-prick

  1 hour post-block

• The percentage of participants with no sensory function (VAS = 0) 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 participants with no sensory function (VAS = 0) 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)

Treatment A

EXPERIMENTAL

Injection around the lateral femoral cutaneous nerve: 8 ml Ropivacaine 0.75 %.

Drug: Ropivacaine

Treatment B

PLACEBO COMPARATOR

Injection around the lateral femoral cutaneous nerve: 8 ml isotonic Saline.

Drug: Isotonic Saline

Interventions

Ropivacaine DRUG

All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B 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 %

Treatment A

Isotonic Saline DRUG

All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B 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 isotonic Saline

Treatment B

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participants who can not cooperate in the study.
• Participant who can not speak or understand danish.
• Allergies to the drugs used in the study.
• Alcohol consumption that exceeds 21 units per week.
• Drug abuse by the investigators judgement.
• Daily consumption 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.
• Diabetes mellitus.
• Pregnant women (women in the fertile age must have used safe contraception and test negative with a urine-HCG to be able to participate in the study).

Sponsors & Collaborators

• Zealand University Hospital: lead
• Naestved Hospital: collaborator

Study Sites (1)

Zealand University Hospital, Køge

Køge, Køge, 4600, Denmark

Location

Related Publications (7)

• 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

• 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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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 4
• 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: October 31, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)