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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02465827
Collaborator
(none)
75
Enrollment
3
Arms
13.9
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: nerve block with ropivacaine
  • Drug: nerve block with ropivacaine and with saline
  • Drug: nerve block with saline
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Selective Blocks for Total Knee Arthroplasty
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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
Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches
Other Names:
  • Saphenous and obturator 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
    nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline
    Other Names:
  • Saph block with ropivacaine and obtur block 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
    Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches
    Other Names:
  • saphenous and obturator nerve block with saline

    		•

    Outcome Measures

    Primary Outcome Measures

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

      NRS 0-10

    Secondary Outcome Measures

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

      NRS 0-10

    2. Total opioid consumption [24 hours]

      mg

    3. Nausea and vomiting [24 hours]

      NRS 0-10

    4. Time to first mobilization [24 hours]

      hours

    5. Length of stay in recovery and hospital [72 hours]

      hours

    6. Number of clinical complications [72 hours]

      total number

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jens Borglum Neimann, Ass professor, PhD, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT02465827
    Other Study ID Numbers:
    • BispebjergH
    First Posted:
    Jun 9, 2015
    Last Update Posted:
    Jun 9, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Ropivacaine

    Study Results

    No Results Posted as of Jun 9, 2015