Post-operative Pain for Total Knee Arthroplasty Clinical Trial
Official title:
Does Single Dose Dexmedetomidine for Procedural Sedation Reduce Post-operative Pain in Total Knee Arthroplasty? A Randomized Control Study
Verified date | June 2016 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control, with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine has been used with a large loading dose and infusion, which has been known to cause dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine produces less negative side-effects, but still effective sedation and reduced post-operative pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only a few studies exist investigating its benefits when administered for sedation purposes with spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The investigators hypothesize that single dose dexmedetomidine for procedural sedation will reduce opioid consumption after total knee arthroplasty (TKA).
Status | Completed |
Enrollment | 54 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adults over 18 years undergoing elective unilateral primary total knee arthroplasty under spinal anesthesia with an American Society of Anesthesiologists physical status class I to III. Exclusion Criteria: - will include contraindication to: - Dexmedetomidine, - morphine, or - Spinal Anesthesia, - as well as anybody with chronic pain being treated by opioids prior to the operation. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Regina Qu'Appelle Health Region | Regina | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Abdallah FW, Abrishami A, Brull R. The facilitatory effects of intravenous dexmedetomidine on the duration of spinal anesthesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jul;117(1):271-8. doi: 10.1213/ANE.0b013e318290c566. Epub 2013 Apr 30. Review. — View Citation
Hong JY, Kim WO, Yoon Y, Choi Y, Kim SH, Kil HK. Effects of intravenous dexmedetomidine on low-dose bupivacaine spinal anaesthesia in elderly patients. Acta Anaesthesiol Scand. 2012 Mar;56(3):382-7. doi: 10.1111/j.1399-6576.2011.02614.x. Epub 2012 Jan 4. — View Citation
Jung SH, Lee SK, Lim KJ, Park EY, Kang MH, Lee JM, Lee JJ, Hwang SM, Hong SJ. The effects of single-dose intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia. J Anesth. 2013 Jun;27(3):380-4. doi: 10.1007/s00540-012-1541-0. Epub 2013 Jan 10. — View Citation
Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29. — View Citation
Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12. — View Citation
Schnabel A, Meyer-Frießem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Morphine Consumption | mg of IV morphine administered via Patient Controlled Analgesia. Patient will be told to deliver morphine dose for pain =>4 from a numerical rating scale for pain from 0 to 10 | 24 Hours | No |
Secondary | Morphine Consumption | mg of IV morphine administered via Patient Controlled Analgesia. Patient will be told to deliver morphine dose for pain =>4 from a numerical rating scale for pain from 0 to 10 | 6, 12 and 24 hours, and time to first morphine request | No |
Secondary | Pain | rated on a numerical rating scale for pain from 0 to 10 | 6, 12 and 24 hours | No |
Secondary | Intraoperative Midazolam | mg usage of IV midazolam for rescue sedation if patient requests more | During the operation | No |
Secondary | Time of readiness of discharge from the post-anesthetic care unit | minutes spent in PACU until criteria met by modified Aldrete Score | Immediately post-operation, average 1 hour | No |
Secondary | Intraoperative heartrate | Lowest heart rate recorded in beats per minute | During the operation | Yes |
Secondary | Duration of sensory blockade two-dermatome sensory regression | Time in Minutes for recovery of 2 dermatomes of sensation | During the operation, and immediately post-operation, average 1 hour | No |
Secondary | Adverse opioid effects of nausea | Binary yes/no if patient experienced nausea | First 24 hours post-operation | Yes |
Secondary | Satisfaction | rated 0-4 | First 24 hours | No |
Secondary | Time to first morphine request | Time in minutes to first morphine request by patient | first 24 hours post-operation | No |
Secondary | Intraoperative blood pressure | Lowest systolic blood pressure recorded in mmHg | During the operation | Yes |
Secondary | Post-operative heartrate | Lowest heartrate in PACU recorded in beats per minute | Immediately after operation in PACU recovery, average 1 hour | Yes |
Secondary | Post-operative blood pressure | Lowest systolic blood pressure recorded in mmHg | Immediately after operation in PACU recovery, average 1 hour | Yes |
Secondary | Duration of Motor blockade | Time in minutes until patient regains knee flexion | During the operation, and immediately post-operation, average 1 hour | No |
Secondary | Adverse opioid effect of vomiting | Binary yes/no if patient experienced vomiting | First 24 hours post-operation | Yes |
Secondary | Adverse opioid effect of constipation | Binary yes/no if patient experienced constipation | First 24 hours post-operation | Yes |
Secondary | Adverse anesthetic effect of shivering | Binary yes/no if patient experienced shivering | Immediately after operation in PACU recovery, average 1 hour | No |
Secondary | Adverse opioid effect of pruritus | Binary yes/no if patient experienced pruritus | First 24 hours post-operation | No |
Secondary | Adverse opioid effect of urinary retention | Binary yes/no if patient experienced urinary retention | First 24 hours post-operation | Yes |