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NCT Number: NCT05597683

Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy

This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.

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Key information

Conditions

Cytoreductive Surgery Hyperthermic Intra-peritoneal Chemotherapy Peritoneal Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Adult patients scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy will be screened for eligibility. After induction of general anesthesia, ultrasound-guided bilateral transmuscular quadratus lomborum block will be done in QL block group. 0.375% ropivacaine will be injected to each side. Patients in control group will receive no block. Multimodal analgesia will be applied to every patient for postoperative pain control. Multimodal analgesic regimen included scheduled administration of acetaminophen, NSAIDs, and rescue opioids. Blinded investigator will assess pain scores at rest and on movement at 6, 12, 24, 48, 72 hours after surgery, analgesic consumptions, nausea, vomiting, and quality of recovery questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)

Exclusion criteria

  • Allergy to local anesthetics or fentanyl
  • Chronic pain
  • Drug abuse
  • Patients who are unable to use patient-controlled analgesia
  • Skin infection at site for quadratus lomborum block
  • pregnant or breatfeeding women
  • Patients who are unable to communicate

Treatment and study plan

Arm I (QL block and multimodal analgesia), Arm II (multimodal analgesia without regional block)

Procedure

Arm I (QL block and multimodal analgesia): Bilateral transmuscular QL block will be done. Postoperative multimodal analgesia including administration of acetaminophen, NSAIDs,nefopam, and rescue opioids

Arm II (multimodal analgesia without regional block): No block will be done. Postoperative multimodal analgesia including administration of acetaminophen, NSAIDs, nefopam, and rescue opioids

Primary outcomes

  1. Total opioid consumption for 24 postoperative hours

    Time frame: 24 hours postoperatively

    Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))

Secondary outcomes

  1. Analgesic consumption

    Time frame: at postoperative 6, 12, 48, 72 hours

    Analgesic consumption at postoperative 6, 12, 48, 72 hours

  2. Resting pain numeric rating scale(NRS)

    Time frame: at postoperative 6, 12, 24, 48, 72 hours

    Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48, 72 hours.

  3. Numeric rating scale of pain during movement

    Time frame: at postoperative 6, 12, 24, 48, 72 hours

    Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48, 72 hours

  4. Time to first rescue analgesics

    Time frame: within post-operative 24 hours

    Time to first rescue analgesics

  5. Rescue analgesics administration

    Time frame: within post-operative 48 hours

    Rescue analgesics administration count

  6. The incidence of post-operative nausea and vomiting

    Time frame: within post-operative 72 hours

    The incidence of post-operative nausea and vomiting

  7. Patient satisfaction with pain control

    Time frame: At post-operative 72 hours

    Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction

  8. Quality of Recovery Questionnaire (15-item Quality of Recovery)

    Time frame: At post-operative 72 hours

    Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

  9. Pattern of injectate spread on ultrasonography

    Time frame: During quadratus lumborum (QL) block procedure

    Pattern of injectate spread on ultrasonography

  10. Numeric rating scale at post anesthetic care unit (PACU)

    Time frame: 30 minutes after the end of operation

    Numeric rating scale at post anesthetic care unit. Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

  11. Time to first ambulation

    Time frame: within post-operative 72 hours

    Time to first ambulation

  12. Length of hospital stay

    Time frame: within postoperative 30 days

    Length of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

SunKyung Park

CONTACT

[email protected]

82-2-2019-4601

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
Aug 15, 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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