Minimum Local Anesthetic Dose for Adductor Canal Block

Neuromuscular Blockade Clinical Trial

Official title:

Minimum Effective Local Anesthetic Dose for Adductor Canal Block for Knee Analgesia − a Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427385
• Other study ID #: 11-0635-A
• Status: Completed
• Phase: N/A
• First received: January 26, 2018
• Last updated: February 8, 2018
• Start date: September 2012
• Est. completion date: August 5, 2014

Study information

• Verified date: February 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the minimum dose of ropivacaine 0.5%, required to produce pain relief without weakening the leg muscles.

Description:

The post-operative period after a Total Knee Arthroplasty (TKA) is known to be especially painful for the first 24 hours. Significant pain can persist up to 3 days in some cases. Successful management of pain post TKA is therefore regarded as essential to early recovery, rehabilitation and timely discharge.

Until now, multiple modes of analgesia have been employed including intravenous patient-controlled analgesia, continuous femoral nerve block and epidural analgesia. These are all effective alternatives but each is limited by side effects. Epidural analgesia provides excellent pain control and has been associated with early rehabilitation despite its negative impact on ambulation in the immediate peri-operative period. Additionally, an increased risk of spinal hematoma has been reported with epidural analgesia and peri-operative low molecular weight heparin prophylaxis. For this reason, epidural analgesia is not routinely offered to patients undergoing TKA today.

A multimodal analgesic approach centered on the use of continuous femoral nerve blocks has been more recently favoured, providing superior analgesia and less opioid-related side effects than a systemic opioid-based regimen. However, femoral nerve blockade is also associated with significant quadriceps muscle weakness, which can impair ambulation, delay physiotherapy and result in accidental fall.

Recent reports suggest that saphenous nerve blockade using an adductor canal approach is a novel technique with which to provide adequate analgesia for major knee surgery. Ultrasound-guided saphenous nerve block in the adductor canal is considered a technically simple and reliable block, providing consistent success. Although traditionally used to provide anesthesia and analgesia to the foot and ankle, recent reports suggest that saphenous nerve blockade in the adductor canal may provide adequate analgesia for major knee surgery. Taking into consideration the anatomy of the adductor canal, it appears possible to target not only the saphenous nerve but also multiple branches of the femoral and obturator nerve.

However, the optimal dose of local anesthetic required to establish knee analgesia without inducing quadriceps weakness has not yet been determined. Identifying an optimal dose would allow for maximum analgesic efficacy with minimal or no motor block, while minimizing other unwanted adverse effects.

This pilot study is designed to determine the optimal dose of ropivacaine 0.5% required to initiate sensory knee analgesia for the post-operative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 5, 2014
• Est. primary completion date: August 5, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• ASA(American Society of Anesthesiologists)physical status classification system I-III

• 18-85 years of age, inclusive

• BMI 18 - 40

• Scheduled for elective total knee replacement under spinal anesthesia or general anesthesia.

Exclusion Criteria:

• Inability or refusal to provide informed consent

• Any contraindication to regional anesthesia (allergy to local anesthetics, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Ropivacaine 0.5%
The volume of local anesthetic Ropivacaine 0.5% will be determined by the response (success or failure of block, 30 minutes after local anesthetic injection) of the previous patient in that group. Block success is defined as an absence of ice sensation in the knee within 30 min of ropivacaine administration accompanied by tolerance to tetanic electrical stimulation (TES) at 60 mA(milliamp) for 5 seconds.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. Epub 2007 May 3. — View Citation

Danelli G, Ghisi D, Fanelli A, Ortu A, Moschini E, Berti M, Ziegler S, Fanelli G. The effects of ultrasound guidance and neurostimulation on the minimum effective anesthetic volume of mepivacaine 1.5% required to block the sciatic nerve using the subgluteal approach. Anesth Analg. 2009 Nov;109(5):1674-8. doi: 10.1213/ANE.0b013e3181b92372. — View Citation

Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. — View Citation

Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. Erratum in: Reg Anesth Pain Med. 2007 Nov-Dec;32(6):536. — View Citation

Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total opioid consumption	Total opioid consumption during the intraoperative phase, post-operative care unit stay, and during the first 48 hours post-surgery	48 hours
Primary	Tolerance to Transcutaneous Electrical Stimulation (TES)	To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.	30 min after ropivacaine injection
Secondary	The degree of motor block following ropivacaine administration	Motor block will be assessed using an isometric force dynamometer	Assessments will start at baseline before ropivacaine injection and every 5 minutes after ropivacaine injection until 45 minutes have passed or until surgery commences, whichever comes first
Secondary	Cold sensation	To determine the minimum effective dose of ropivacaine in the adductor canal block to initiate sensory analgesia in the knee. Complete sensory anesthesia in the knee following adductor canal block 30 minutes after ropivacaine administration.	30 min after ropivacaine injection