Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Epidural morphine
- Conditions
- Adult Patients
- Sponsor
- Peking University First Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital
Eligibility Criteria
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.
Arms & Interventions
Epidural morphine
1. Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Epidural morphine
Epidural morphine
1. Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Single femoral nerve block
Epidural morphine
1. Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Intravenous morphine analgesia
Epidural placebo
1. Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Epidural placebo
Epidural placebo
1. Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Single femoral nerve block
Epidural placebo
1. Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. 2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 3. 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.
Intervention: Intravenous morphine analgesia
Outcomes
Primary Outcomes
Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
Time Frame: 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 Outcomes
- NRS pain scores (at rest and with movement) at various timepoints after surgery(At 6, 12, 24, 36 and 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.)
- Time to begin functional exercise and ground walking(During hospital stay, up to 1 week after surgery.)
- Cumulative morphine consumption(Until 48 hours after surgery.)
- Patient's satisfaction with analgesia(At 48 hours after surgery.)
- The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index(At 30 days after surgery.)
- Length of stay in hospital after surgery(Until hospital discharge up to 30 days after surgery.)
- Incidence of postoperative complication(Until 30 days after surgery.)
- Quality of life (SF-12) at 30 days after surgery(At 30 days after surgery.)