Total Knee Arthroplasty Clinical Trial
Official title:
Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
NCT number | NCT03203967 |
Other study ID # | 2017[1308] |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | May 30, 2018 |
Verified date | May 2018 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used for postoperative analgesia for patients after TKA in the hospital of the investigators. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.
Status | Completed |
Enrollment | 110 |
Est. completion date | May 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Adult patients (age of 18 years or older); - American Society of Anesthesiologists classification I-III; - Scheduled to undergo unilateral TKA under combined spinal and epidural anesthesia. Exclusion Criteria: - Age higher than 90 years old; - Presence of any contraindication to neuraxial block or peripheral nerve block; - Continuous use of opioid analgesics during the last month; - Unable to understand Numeric Rating Scale for pain evaluation or existence of language barrier; - Severe renal insufficiency (requirement of renal replacement therapy); - History of asthma; - Recruited in another clinical trials. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher) | Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement. | Until 48 hours after surgery. | |
Secondary | NRS pain scores (at rest and with movement) at various timepoints after surgery | Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement. | At 6, 12, 24, 36 and 48 hours after surgery. | |
Secondary | Cumulative morphine consumption | Cumulative morphine consumption during 48 hours after surgery. | Until 48 hours after surgery. | |
Secondary | Recovery of motor function of the lower limb from blockade | Modified Bromage scale (0 = no blockade: extended limb lift off the bed; 1 = flexion/extension at knee and ankle joint; 2 = no flexion/extension at knee or ankle joint; 3 = complete blockade). | At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery. | |
Secondary | Time to begin functional exercise and ground walking | Time to begin functional exercise and ground walking | During hospital stay, up to 1 week after surgery. | |
Secondary | Patient's satisfaction with analgesia | Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory. | At 48 hours after surgery. | |
Secondary | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Until hospital discharge up to 30 days after surgery. | |
Secondary | Incidence of postoperative complication | Incidence of postoperative complication within 30 days after surgery. | Until 30 days after surgery. | |
Secondary | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. | At 30 days after surgery. | |
Secondary | Quality of life (SF-12) at 30 days after surgery | Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery. | At 30 days after surgery. |
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