Clinical trial NCT03203967: Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty
Official title: Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Patients
Total Knee Arthroplasty
Epidural Analgesia
Femoral Nerve Block
Analgesic Adverse Reaction
Keywords: Adults
Unilateral TKA
Single femoral nerve block
Low-dose epidural morphine
Effect of postoperative analgesia
Quality of life
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
timeFrame: Until 48 hours after surgery.
Secondary outcomes:
measure: NRS pain scores (at rest and with movement) at various timepoints after surgery
timeFrame: At 6, 12, 24, 36 and 48 hours after surgery.
measure: Cumulative morphine consumption
timeFrame: Until 48 hours after surgery.
measure: Recovery of motor function of the lower limb from blockade
timeFrame: At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery.
measure: Time to begin functional exercise and ground walking
timeFrame: During hospital stay, up to 1 week after surgery.
measure: Patient's satisfaction with analgesia
timeFrame: At 48 hours after surgery.
measure: Length of stay in hospital after surgery
timeFrame: Until hospital discharge up to 30 days after surgery.
measure: Incidence of postoperative complication
timeFrame: Until 30 days after surgery.
measure: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
timeFrame: At 30 days after surgery.
measure: Quality of life (SF-12) at 30 days after surgery
timeFrame: At 30 days after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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