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

Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: ropivacaine 0.2%

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent bolus; ropivacaine 0.2%, 21 ml every 3 hours	Drug: ropivacaine 0.2%; Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM
Active Comparator: Continuous infusion; ropivacaine 0.2%, 7ml/h	Drug: ropivacaine 0.2%; Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 days postoepratively
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).	2 days postoperatively
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.	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	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	Time (seconds) to perform the Timed Up and Go test at 12 pm on POD 1 and 2.	1 and 2 days postoperatively
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.	1 and 2 days postoperatively
6 min walk test	Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.	1 and 2 days postoperativley

Collaborators and Investigators

• Sponsor: Pia Jaeger
• Collaborators: University of California, San Diego; Bispebjerg Hospital; Smiths Medical, ASD, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SM3-PJ-14; 2014-005642-22 (EudraCT Number)