NCT02539628

Brief Summary

The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2015

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

March 13, 2015

Last Update Submit

April 27, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Difference in total opioid consumption (patient controlled analgesia pump and any potential rescue administration) between groups, from end of surgery until 12 pm on postoperative day (POD) 2.

    2 days postoperative

Secondary Outcomes (7)

  • Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)

    2 days postoepratively

  • Pain at rest as assessed by the VAS pain scores

    2 days postoperatively

  • Pain during the Timed Up and Go test as assessed by the VAS

    1 and 2 days postoperatively

  • Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2

    1 and 2 days postoperatively

  • Timed Up and Go test

    1 and 2 days postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Intermittent bolus

EXPERIMENTAL

ropivacaine 0.2%, 21 ml every 3 hours

Drug: ropivacaine 0.2%

Continuous infusion

ACTIVE COMPARATOR

ropivacaine 0.2%, 7ml/h

Drug: ropivacaine 0.2%

Interventions

ropivacaine 0.2%DRUG

Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Continuous infusionIntermittent bolus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for total knee arthroplasty in spinal anesthesia
  • Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
  • American society of anesthesiologists 1-3
  • Ability to perform a timed up and go test preoperatively

You may not qualify if:

  • Patients who cannot cooperate
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to the medicines used in the study
  • Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
  • Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
  • Rheumatoid arthritis
  • BMI \> 40
  • Neuromuscular pathology in the lower limbs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.

    PMID: 29293181DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

March 13, 2015

First Posted

September 3, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

DK(1)