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

Selective Blocks for Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Drug: nerve block with ropivacaine; Drug: nerve block with ropivacaine and with saline; Drug: nerve block with saline

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively	NRS 0-10	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively	NRS 0-10	24 hours
Total opioid consumption	mg	24 hours
Nausea and vomiting	NRS 0-10	24 hours
Time to first mobilization	hours	24 hours
Length of stay in recovery and hospital	hours	72 hours
Number of clinical complications	total number	72 hours

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: BispebjergH