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NCT Number: NCT06205199

Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty

The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.

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Key information

Conditions

Postoperative Analgesia

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Jilin University

Changchun, Jilin, China

About this study

For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 55 and 80 years old.
  • ASA grade I to III.
  • BMI:20-29kg/m2.
  • No recent use of sedatives, opioids, or other analgesics.
  • There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases.
  • Patients were willing to participate in the study and signed the informed consent.

Exclusion criteria

  • The patient has mental illness or cannot cooperate with the completion of spinal anesthesia.
  • The patient had a history of spinal surgery and spinal deformity.
  • Patients had a history of opioid intolerance or adverse reactions.
  • puncture site infection, coagulopathy or recent use of anticoagulant drugs.
  • History of allergy to local anesthetics.
  • Failed puncture.
  • Unable to cooperate to complete the research process.

Treatment and study plan

Hydromorphone was injected into the subarachnoid space

Drug

The dose of hydromorphone is 50 micrograms

Primary outcomes

  1. Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.

    Time frame: 6, 12, 18, and 24 hours after anesthesia

    The NRS scale was used to evaluate pain scores at rest at 6, 12, 18, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)

  2. Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.

    Time frame: 6, 12, 18, and 24 hours after anesthesia

    NRS rating scale was used to evaluate pain score during movement at 6 hours, 12 hours, 18 hours, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)

Secondary outcomes

  1. Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia

    Time frame: 6, 12, 18, and 24 hours after anesthesia

    RASS was used to assess sedation and agitation at 6, 12, 18, and 24 hours after anesthesia；Richmond Agitation and Sedation Scale(RASS,a 10-point scale where -5=unwakeable,0=clear and calm,+4=aggressive)

  2. The number of effective compressions of PCIA at 24 hours after surgery

    Time frame: Postoperative 24 hours

    Effective number of PCIA compressions during the 24 hours after surgery

  3. The proportion of the required additional analgesia after 24 hours

    Time frame: Postoperative 24 hours

    The proportion of patients requiring additional analgesia 24 hours after surgery in the whole group

  4. Total non-steroidal analgesic drug consumption 48 hours after surgery

    Time frame: Postoperative 48 hours

    Non-steroidal analgesic consumption at 48 hours after surgery

  5. Total opioid analgesic consumption at 48 hours after surgery

    Time frame: Postoperative 48 hours

    Opioid analgesic consumption at 48 hours after surgery

  6. The proportion of getting out of bed within 48h

    Time frame: Postoperative 48 hours

    The proportion of people who got out of bed 48 hours after operation in the whole group

  7. Satisfaction with postoperative analgesia

    Time frame: 5 days after surgery

    Patient satisfaction with postoperative analgesia；0=unsatisfied, 10=fully satisfied

  8. Retention time of urinary tube

    Time frame: 5 days after surgery

    Retention time of urinary catheter after surgery

  9. Length of postoperative hospital stay

    Time frame: 2 weeks after surgery

    The hospitalization days after surgery

  10. The incidence of postoperative nausea or vomiting

    Time frame: Postoperative 48 hours

    Nausea and vomiting accounted for the proportion of the whole group

  11. The incidence of postoperative pruritus

    Time frame: Postoperative 48 hours

    Pruritus accounted for the proportion of the whole group

  12. The incidence of intraoperative hypotension

    Time frame: During the operation

    Systolic blood pressure drops to 20% of basal blood pressure or systolic blood pressure drops below 90mmHg

  13. The incidence of intraoperative hypoxemia

    Time frame: During the operation

    SpO2 drop below 90%

  14. Incidence of intraoperative HR reduction

    Time frame: During the operation

    HR < 45 beats /min

Sponsors and collaborators

Lead sponsor

Second Hospital of Jilin University

Other

Registry information

Official study title

Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Jan 24, 2024

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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