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NCT Number: NCT03203967

Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 placebo

Procedure

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

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.

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.

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Cumulative morphine consumption

    Time frame: Until 48 hours after surgery.

    Cumulative morphine consumption during 48 hours after surgery.

  3. Recovery of motor function of the lower limb from blockade

    Time frame: 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).

  4. Time to begin functional exercise and ground walking

    Time frame: During hospital stay, up to 1 week after surgery.

    Time to begin functional exercise and ground walking

  5. Patient's satisfaction with analgesia

    Time frame: At 48 hours after surgery.

    Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.

  6. Length of stay in hospital after surgery

    Time frame: Until hospital discharge up to 30 days after surgery.

    Length of stay in hospital after surgery

  7. Incidence of postoperative complication

    Time frame: Until 30 days after surgery.

    Incidence of postoperative complication within 30 days after surgery.

  8. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

    Time frame: At 30 days after surgery.

    Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  9. Quality of life (SF-12) at 30 days after surgery

    Time frame: At 30 days after surgery.

    Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2017
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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