Total Knee Arthroplasty Clinical Trial
Official title:
Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
NCT number | NCT02798835 |
Other study ID # | H16-01058 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 2016 |
Verified date | September 2020 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.
Status | Completed |
Enrollment | 180 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent - Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3 - Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents - Patients must be able to understand and be able to use patient controlled analgesia - Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia Exclusion Criteria: - Patients with a contraindication to neuraxial and/or regional anaesthesia - Patients with an allergy to local anaesthetics - Patients who have chronic pain not related to their knee joint - Patients with chronic opioid use (daily or almost daily use >3 months) - Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus) - Patients with pre-existing neuropathy - Patients with hepatic failure - Patients with renal failure with eGFR<60 - Patients with allergy to ketorolac or NSAIDs |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of British Columbia |
Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210. Erratum in: Reg Anesth Pain Med. 2015 Jul-Aug;40(4):398. — View Citation
Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. — View Citation
Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6. — View Citation
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b. — View Citation
Jenstrup MT, Jæger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4. — View Citation
Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119. — View Citation
Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The impact of analgesic modality on early ambulation following total knee arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):334-9. doi: 10.1097/AAP.0b013e318296b6a0. — View Citation
Rahangdale R, Kendall MC, McCarthy RJ, Tureanu L, Doty R Jr, Weingart A, De Oliveira GS Jr. The effects of perineural versus intravenous dexamethasone on sciatic nerve blockade outcomes: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2014 May;118(5):1113-9. doi: 10.1213/ANE.0000000000000137. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adductor Canal Block Complications | Incidence of catheter dislodgement or site infection | From time of catheter insertion until catheter removal, up to Day2/48 hours | |
Other | Nerve Block Complications | Nerve block complications at any time point during study | 0 to 48 hours | |
Primary | Cumulative 24 Hour Oral Morphine Equivalent Consumption | Post-operative analgesia at 24 hours | 24 hours (Day 1) | |
Secondary | Cumulative 12 Hour Oral Morphine Equivalent Consumption | Post-operative analgesia at 12 hours | 12 hours (Day 0) | |
Secondary | Cumulative 48 Hour Oral Morphine Equivalent Consumption | Post-operative analgesia at 48 hours | 48 hours (Day 2) | |
Secondary | Pain Score | Patient's level of pain using NRS (Numeric Ratings Scale) pain scale where the range is 0 (no pain) to 10 (worst pain) | 12, 24 and 48 hours | |
Secondary | Quality of Recovery (QoR-40) | Quality of recovery measured using the QoR-40 at 48 hours postoperatively. This is a validated scale where a higher score denotes better recovery/satisfaction after surgery. The range is 40-200. | 48 hours (Day 2) | |
Secondary | Length of Stay | Time to hospital discharge | From surgical date until hospital discharge, up to 3 weeks | |
Secondary | Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics | Number of Participants with Nausea/Vomiting requiring anti-emetics from 0-48 hours after surgery. | 0 to 48 hours | |
Secondary | Time to First Use of PCA | from time zero to first press of PCA button | 0 to 48 hours |
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