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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539628
• Other study ID #: SM3-PJ-14
• Secondary ID: 2014-005642-22
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2015
• Last updated: April 27, 2017
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• ropivacaine 0.2%
Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital	Gentofte	Hellerup

Sponsors (4)

Lead Sponsor	Collaborator
Pia Jaeger	Bispebjerg Hospital, Smiths Medical, ASD, Inc., University of California, San Diego

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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