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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: ropivacaine 0.2%

• Registration Number: NCT02539628
• Lead Sponsor: Pia Jaeger

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	ropivacaine 0.2%	ropivacaine 0.2%, 7ml/h
Intermittent bolus	ropivacaine 0.2%	ropivacaine 0.2%, 21 ml every 3 hours

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	2 days postoperative	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

Name	Time	Method
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	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	1 and 2 days postoperatively	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	1 and 2 days postoperatively	Number of patients able to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)	2 days postoepratively	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).
6 min walk test	1 and 2 days postoperativley	Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.
Pain at rest as assessed by the VAS pain scores	2 days postoperatively	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	1 and 2 days postoperatively	Worst pain (VAS, 0-100 mm) during the Timed Up and Go test at 12 pm on POD 1 and 2.

Trial Locations

Locations (1)

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark