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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.

NCT02374008

Peripheral Nerve Block Pain

COMPLETED PHASE4

Genicular Nerve Block for Total Knee Arthroplasty

NCT03706313

Post-operative Pain

COMPLETED PHASE4

Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

NCT01837394

Postoperative Pain Postoperative Nausea and Vomiting Postoperative Function Level

COMPLETED PHASE4

Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty

NCT02067078

Total Knee Arthroplasty Pain Nerve Blocks

COMPLETED PHASE4

USG Nerve Blocks for ACL Reconstruction

NCT01840800

Pain, Postoperative

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Arthroplasty, Total

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

nerve block with ropivacaine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

nerve block with ropivacaine and with saline

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

nerve block with saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nerve block with ropivacaine

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

Intervention Type 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

Intervention Type DRUG

nerve block with saline

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Saphenous and obturator nerve block with ropivacaine Saph block with ropivacaine and obtur block with saline saphenous and obturator nerve block with saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No