Continuous Versus Single-Shot Adductor Canal Block in Total Knee Arthroplasty

NCT03145584 | Completed

• 1 other identifier: ECM 4 ppp 070715
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block has recently been shown to improve the pain control of patients following TKA. It is not known whether a single shot technique or a continuous catheter-based infusion technique provides optimal analgesia. The investigators hypothesize that a continuous technique would provide better analgesia and permit patients to achieve objective measures of recovery following TKA than a single shot technique.

Conditions

Pain, Postoperative

Keywords

Total Knee Arthroplasty; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Degree of active knee flexion

  The degree of active knee flexion was measured during physiotherapy using callipers

  During the post operative physiotherapy session on Post-operative Day (POD) 2

Secondary Outcomes (13)

• Numerical rating pain score (NRS)

  8pm on the evening of surgery

• Numerical rating pain score (NRS)

  8am POD 1

• Numerical rating pain score (NRS)

  8pm POD 1

• Numerical rating pain score (NRS)

  8am POD 2

• Numerical rating pain score (NRS)

  8pm POD 2

Study Arms (2)

Continuous Adductor Canal Saphenous Catheter

ACTIVE COMPARATOR

Participants in this group were randomly allocated to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A PERINEURAL CATHETER WAS INSERTED IMMEDIATELY AFTER INJECTION OF THE INITIAL BOLUS OF LOCAL ANAESTHETIC. THE CATHETER WAS CONNECTED TO A PAJUNK FUSERPUMP CONTAINING 350 ML OF 0.15625% BUPIVACAINE AND INFUSED AT 8ML/HR.

Drug: Continuous Bupivacaine via Adductor Canal Saphenous Catheter

Single Shot Adductor Canal Saphenous Block

SHAM COMPARATOR

Participants in this group were randomly allocated NOT to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A SHAM CATHETER WAS PLACED ON THE SURFACE OF THE LEG AND COVERED BY AN OPAQUE DRESSING TO CONCEAL THE INSERTION SITE. ALL PATIENTS HAD THE PROXIMAL END OF THEIR CATHETER ATTACHED TO PORTABLE ELASTOMERIC PUMPS (PAJUNK FUSERPUMP 350 ML) CONCEALED IN OPAQUE BAGS TO PREVENT PATIENTS AND ASSESSORS FROM DETERMINING WHICH PUMPS WERE ACTUALLY FUNCTIONING. THESE PUMPS FUNCTION WITHOUT A MOTOR AND SO MAKE NO SOUND.

Other: Single Shot Adductor Canal Saphenous Block with Bupivacaine

Interventions

Continuous Bupivacaine via Adductor Canal Saphenous Catheter DRUG

12.5 mg/hr of bupivacaine was administered continuously via a paraneural catheter for 48 hours following surgery to determine whether superior analgesia was obtained when compared to single shot block with a sham catheter.

Also known as: Active Comparator

Continuous Adductor Canal Saphenous Catheter

Single Shot Adductor Canal Saphenous Block with Bupivacaine OTHER

A sham catheter was placed on the skin and covered in a dressing to blind the patient, data collector and investigator as to group allocation

Also known as: Sham Comparator

Single Shot Adductor Canal Saphenous Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled unilateral total knee arthroplasty,
• ASA physical status I to III,
• age \> 18 years.

You may not qualify if:

• Body Mass Index \>35,
• pre-existing lower extremity neurologic abnormalities,
• infection, history of chronic opioid use,
• pregnancy, contraindications to peripheral nerve block or central neuraxial blockade,
• allergy or contraindications to local anesthetics or drugs that would be used for multimodal analgesia,
• inadequate command of English
• refusal of spinal anaesthetic

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Brian O'Donnell

Cork, Ireland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

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

Study Officials

• Frank Loughnane, MB, FCARCSI

  Cork University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist and Clinical Senior Lecturer

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: May 9, 2017
• Study Start: July 1, 2015
• Primary Completion: December 20, 2015
• Study Completion: December 31, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)