Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03203967

Collaborator

(none)

110

Enrollment

Location

Arms

10.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Patients Total Knee Arthroplasty Epidural Analgesia Femoral Nerve Block Analgesic Adverse Reaction	Procedure: Epidural morphine Procedure: Epidural placebo Procedure: Single femoral nerve block Drug: Intravenous morphine analgesia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural morphine Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 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.	Procedure: Epidural 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. Procedure: Single 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. Drug: Intravenous 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.
Placebo Comparator: Epidural placebo Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 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.	Procedure: Epidural placebo 5 ml normal saline is administered through the epidural catheter at the end of surgery. Procedure: Single 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. Drug: Intravenous 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.

Arm

Intervention/Treatment

Experimental: Epidural morphine

Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 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.

Procedure: Epidural 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.

Procedure: Single 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.

Drug: Intravenous 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.

Placebo Comparator: Epidural placebo

Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery. 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.

Procedure: Epidural placebo

5 ml normal saline is administered through the epidural catheter at the end of surgery.

Procedure: Single 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.

Drug: Intravenous morphine analgesia

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
Length of stay in hospital after surgery [Until hospital discharge up to 30 days after surgery.]
Length of stay in hospital after surgery
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.