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Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

Primary Purpose

Adult Patients, Total Knee Arthroplasty, Epidural Analgesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Epidural morphine
Epidural placebo
Single femoral nerve block
Intravenous morphine analgesia
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adult Patients focused on measuring Adults, Unilateral TKA, Single femoral nerve block, Low-dose epidural morphine, Effect of postoperative analgesia, Quality of life

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Epidural morphine

Epidural placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Cumulative morphine consumption
Cumulative morphine consumption during 48 hours after surgery.
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).
Time to begin functional exercise and ground walking
Time to begin functional exercise and ground walking
Patient's satisfaction with analgesia
Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Incidence of postoperative complication
Incidence of postoperative complication within 30 days after surgery.
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Quality of life (SF-12) at 30 days after surgery
Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.

Full Information

First Posted
May 30, 2017
Last Updated
May 31, 2018
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03203967
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural morphine
Arm Type
Experimental
Arm Description
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.
Arm Title
Epidural placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Epidural morphine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Epidural placebo
Intervention Description
5 ml normal saline is administered through the epidural catheter at the end of surgery.
Intervention Type
Procedure
Intervention Name(s)
Single femoral nerve block
Intervention Description
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
Intervention Type
Drug
Intervention Name(s)
Intravenous morphine analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher)
Description
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.
Time Frame
Until 48 hours after surgery.
Secondary Outcome Measure Information:
Title
NRS pain scores (at rest and with movement) at various timepoints after surgery
Description
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.
Time Frame
At 6, 12, 24, 36 and 48 hours after surgery.
Title
Cumulative morphine consumption
Description
Cumulative morphine consumption during 48 hours after surgery.
Time Frame
Until 48 hours after surgery.
Title
Recovery of motor function of the lower limb from blockade
Description
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 Frame
At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery.
Title
Time to begin functional exercise and ground walking
Description
Time to begin functional exercise and ground walking
Time Frame
During hospital stay, up to 1 week after surgery.
Title
Patient's satisfaction with analgesia
Description
Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.
Time Frame
At 48 hours after surgery.
Title
Length of stay in hospital after surgery
Description
Length of stay in hospital after surgery
Time Frame
Until hospital discharge up to 30 days after surgery.
Title
Incidence of postoperative complication
Description
Incidence of postoperative complication within 30 days after surgery.
Time Frame
Until 30 days after surgery.
Title
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Description
Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Time Frame
At 30 days after surgery.
Title
Quality of life (SF-12) at 30 days after surgery
Description
Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.
Time Frame
At 30 days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD,PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

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