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NCT Number: NCT04668391

Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery

This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.

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Key information

Conditions

Liver Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age≥18 years
  • ASA I-III
  • Open liver surgery

Exclusion criteria

  • Contraindication to nerve block or epidural puncture
  • Chronic use of opioids or NSAIDs
  • Refused to participate in the study

Treatment and study plan

Ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament

Procedure

Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.

Thoracic epidural analgesia

Procedure

A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.

Primary outcomes

  1. NRS (numeric rating scale) score for coughing pain

    Time frame: at 24 hours after surgery

    Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)

Secondary outcomes

  1. NRS score for rest and coughing pain

    Time frame: at 1, 6, 24, 48, 72 hours after surgery

    Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain)

  2. consumption of opioid converted to IV morphine equivalents

    Time frame: during 24 hours after surgery

    opioids given postoperatively converted to IV morphine equivalents

  3. Numbers of additional analgesics

    Time frame: during 72 hours after surgery

    Additional rescue analgesics were used when pain relief was inadequate (NRS >3). The choice of rescue analgesic was oxydone 5-10mg.

  4. The incidence of postoperative hypotension

    Time frame: during 72 hours after surgery

    Adverse reactions related to analgesia

  5. The incidence of nausea and vomiting

    Time frame: during 72 hours after surgery

    Adverse reactions related to analgesia

  6. The incidence of pruritus

    Time frame: during 72 hours after surgery

    Adverse reactions related to analgesia

  7. The incidence of respiratory depression

    Time frame: during 72 hours after surgery

    Adverse reactions related to analgesia

  8. Time to ambulation in days

    Time frame: through study completion, an average of 2-3 days

    Postoperative ambulation time

  9. Time to eat in days

    Time frame: through study completion, an average of 2-3 days

    Time to start eating after surgery

  10. Time to flatus in hours

    Time frame: through study completion, an average of 40-50 hours

    Time to flatus after surgery

  11. Time to defecation in hours

    Time frame: through study completion, an average of 60-70 hours

    Time to defecation after surgery

  12. Time to urethral catheter removal in hours

    Time frame: through study completion, an average of 60-70 hours

    Time tourethral catheter removal after surgery

  13. Postoperative hospital stay in days

    Time frame: through study completion, an average of 7-8 days

    The time from operation to discharge

  14. Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication

    Time frame: One month after surgery

    Postoperative Clavien-Dindo complication classification

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Ultrasound-guided Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Versus Thoracic Epidural Analgesia After Open Liver Surgery: A Prospective, Randomized, Controlled, Noninferiority Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Jul 6, 2022

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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