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Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
ropivacaine 0.2%
Sponsored by
Pia Jaeger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent bolus

Continuous infusion

Arm Description

ropivacaine 0.2%, 21 ml every 3 hours

ropivacaine 0.2%, 7ml/h

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)
Visual analogue scale (VAS) pain scores (0-100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points (Day of surgery (DOS): 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Pain at rest as assessed by the VAS pain scores
VAS pain scores (0-100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points (DOS: 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Pain during the Timed Up and Go test as assessed by the VAS
Worst pain (VAS, 0-100 mm) during the Timed Up and Go test at 12 pm on POD 1 and 2.
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2.
Timed Up and Go test
Time (seconds) to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Number of patients able to perform the Timed Up and Go test
Number of patients able to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
6 min walk test
Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.

Full Information

First Posted
March 13, 2015
Last Updated
April 27, 2017
Sponsor
Pia Jaeger
Collaborators
University of California, San Diego, Bispebjerg Hospital, Smiths Medical, ASD, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02539628
Brief Title
Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption
Official Title
Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pia Jaeger
Collaborators
University of California, San Diego, Bispebjerg Hospital, Smiths Medical, ASD, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent bolus
Arm Type
Experimental
Arm Description
ropivacaine 0.2%, 21 ml every 3 hours
Arm Title
Continuous infusion
Arm Type
Active Comparator
Arm Description
ropivacaine 0.2%, 7ml/h
Intervention Type
Drug
Intervention Name(s)
ropivacaine 0.2%
Intervention Description
Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM
Primary Outcome Measure Information:
Title
Total opioid consumption
Description
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.
Time Frame
2 days postoperative
Secondary Outcome Measure Information:
Title
Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)
Description
Visual analogue scale (VAS) pain scores (0-100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points (Day of surgery (DOS): 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Time Frame
2 days postoepratively
Title
Pain at rest as assessed by the VAS pain scores
Description
VAS pain scores (0-100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points (DOS: 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Time Frame
2 days postoperatively
Title
Pain during the Timed Up and Go test as assessed by the VAS
Description
Worst pain (VAS, 0-100 mm) during the Timed Up and Go test at 12 pm on POD 1 and 2.
Time Frame
1 and 2 days postoperatively
Title
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2
Description
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2.
Time Frame
1 and 2 days postoperatively
Title
Timed Up and Go test
Description
Time (seconds) to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Time Frame
1 and 2 days postoperatively
Title
Number of patients able to perform the Timed Up and Go test
Description
Number of patients able to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Time Frame
1 and 2 days postoperatively
Title
6 min walk test
Description
Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.
Time Frame
1 and 2 days postoperativley

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29293181
Citation
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.
Results Reference
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Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

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