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CompletedNCT02465827Updated Jun 9, 2015

Ultrasound-guided Selective Blockade of the Saphenous and Obturator Nerves Following Total Knee Arthroplasty

A Phase 4 interventional study of nerve block with ropivacaine and nerve block with ropivacaine and with saline in Knee Arthroplasty, Total, sponsored by Bispebjerg Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-09.

Sponsored by Bispebjerg Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.

Read the detailed description

A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.

02

Conditions studied

  • Knee Arthroplasty, Total
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In context

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. American Society of Anesthesiologists' physical classification I-III
  2. Age ≥ 18 years undergoing primary unilateral total knee arthroplasty

Exclusion criteria

Exclusion Criteria:

  1. Inability to cooperate
  2. Inability to speak and understand Danish
  3. Allergy to any drugs used in the study
  4. Drug or alcohol abuse
  5. Pregnancy or nursing
  6. Opioid abusers
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    Saphenous and obturator nerve block

    5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of ropivacaine 0,75% for the obturator nerve block. Ropivacaine 0.75% for nerve blockades for both nerves mentioned.

    Drug: nerve block with ropivacaine

  • Active comparator
    Saphenous nerve block

    5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Ropivacaine 0.75% for the saphenous nerve block and saline for the obturator nerve block

    Drug: nerve block with ropivacaine and with saline

  • Placebo comparator
    Placebo nerve block

    5 ml of isotonic saline for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block. Saline for nerve blockades for both nerves mentioned.

    Drug: nerve block with saline

Interventions

  • Drugnerve block with ropivacaine

    Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches

    Also known as: Saphenous and obturator nerve block with ropivacaine

  • Drugnerve block with ropivacaine and with saline

    nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline

    Also known as: Saph block with ropivacaine and obtur block with saline

  • Drugnerve block with saline

    Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches

    Also known as: saphenous and obturator nerve block with saline

06

What researchers measure

Primary outcomes

  1. Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively

    NRS 0-10

    Time frame: 24 hours

Secondary outcomes

  1. Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively

    NRS 0-10

    Time frame: 24 hours

  2. Total opioid consumption

    mg

    Time frame: 24 hours

  3. Nausea and vomiting

    NRS 0-10

    Time frame: 24 hours

  4. Time to first mobilization

    hours

    Time frame: 24 hours

  5. Length of stay in recovery and hospital

    hours

    Time frame: 72 hours

  6. Number of clinical complications

    total number

    Time frame: 72 hours

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02465827
Lead sponsor
Bispebjerg Hospital
Responsible party
Jens Borglum Neimann (Ass professor, PhD, Bispebjerg Hospital) — Principal investigator
First posted
Jun 9, 2015
Start date
Jan 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Jun 9, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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