Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

NCT03203967 | Completed

• 1 other identifier: 2017[1308]
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Until 48 hours after surgery.

Secondary Outcomes (9)

• NRS pain scores (at rest and with movement) at various timepoints after surgery

  At 6, 12, 24, 36 and 48 hours after surgery.

• Cumulative morphine consumption

  Until 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.

• Patient's satisfaction with analgesia

  At 48 hours after surgery.

Study Arms (2)

Epidural morphine

EXPERIMENTAL

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.

Procedure: Epidural morphine; Procedure: Single femoral nerve block; Drug: Intravenous morphine analgesia

Epidural placebo

PLACEBO COMPARATOR

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.

Procedure: Epidural placebo; Procedure: Single femoral nerve block; Drug: Intravenous morphine analgesia

Interventions

Epidural morphine PROCEDURE

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.

Epidural morphine

Epidural placebo PROCEDURE

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

Epidural placebo

Single femoral nerve block PROCEDURE

Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.

Epidural morphine; Epidural placebo

Intravenous morphine analgesia DRUG

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 morphine; Epidural placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (23)

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  PMID: 31260468 DERIVED

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 29, 2017
• Study Start: July 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)