Adult Patients, Total Knee Arthroplasty, Epidural Analgesia, Femoral Nerve Block, Analgesic Adverse Reaction
Conditions
Keywords
Adults, Unilateral TKA, Single femoral nerve block, Low-dose epidural morphine, Effect of postoperative analgesia, Quality of life
Brief summary
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.
Detailed description
Total knee arthroplasty (TKA) is an important therapy for patients with serious knee osteoarthritis in order to improve quality of life and relieve pain. But a large number of patients who undergo this surgery experience moderate to severe postoperative pain. Previously, the investigators used single femoral nerve blockade combined with patient-controlled intravenous analgesia for postoperative analgesia for patients after TKA. 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.
Interventions
PROCEDUREEpidural morphine
2 mg of morphine (0.4 mg/ml morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
PROCEDUREEpidural placebo
5 ml normal saline is administered through the epidural catheter at the end of surgery.
PROCEDURESingle femoral nerve block
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
DRUGIntravenous morphine analgesia
Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/ml morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 ml/h.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher) | Until 48 hours 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative morphine consumption | Until 48 hours after surgery. | Cumulative morphine consumption during 48 hours after surgery. |
| Recovery of motor function of the lower limb from blockade | At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery. | 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). |
| Time to begin functional exercise and ground walking | During hospital stay, up to 1 week after surgery. | Time to begin functional exercise and ground walking |
| Patient's satisfaction with analgesia | At 48 hours after surgery. | Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory. |
| NRS pain scores (at rest and with movement) at various timepoints after surgery | At 6, 12, 24, 36 and 48 hours 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. |
| Incidence of postoperative complication | Until 30 days after surgery. | Incidence of postoperative complication within 30 days after surgery. |
| The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | At 30 days after surgery. | Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. |
| Quality of life (SF-12) at 30 days after surgery | At 30 days after surgery. | Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery. |
| Length of stay in hospital after surgery | Until hospital discharge up to 30 days after surgery. | Length of stay in hospital after surgery |
Countries
China
Outcome results
None listed