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Completed

NCT Number: NCT05480111

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English or Spanish speaking
  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Planned laparoscopic or robotic hysterectomy

Exclusion criteria

  • History of chronic pain requiring preoperative opioids, Known alcoholism disorder
  • Congenital coagulopathy,
  • Localized soft tissue infection,
  • Use of anticoagulants,
  • Dementia, inability or refusal to provide consent for the surgery
  • Morbid obesity (BMI > 50), due to expected technical difficulty to achieve the block

Treatment and study plan

Local anesthesia at incision site

Drug

20 ml of 0.25% Bupivacaine will be given at incision site

Sham QL

Drug

20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Sham Local

Drug

20 mls of normal saline given at incision site

QL

Drug

QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Primary outcomes

  1. Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain.

  2. Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome.

  3. Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome.

  4. Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome.

  5. Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome.

  6. Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

    Time frame: 24 hours after anesthesia

    The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome

Secondary outcomes

  1. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: Post anesthesia care unit (PACU) immediately postoperatively

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  2. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: At the time of first opiate administration(upto one day after surgery)

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  3. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: At the time of discharge (upto 3 days after surgery)

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  4. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: Day 1 (24+/=4 hours post surgery)

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  5. Pain at Dynamic as Assessed by the Visual Analog Scale

    Time frame: Day 1 (24+/=4 hours post surgery)

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  6. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: Day 14 post surgery

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  7. Pain at Dynamic as Assessed by the Visual Analog Scale

    Time frame: Day 14 post surgery

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  8. Pain at Rest as Assessed by the Visual Analog Scale

    Time frame: 6 weeks post surgery

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  9. Pain at Dynamic as Assessed by the Visual Analog Scale

    Time frame: 6 weeks post surgery

    0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

  10. Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)

    Time frame: in PACU(upto 8 hours after surgery)

  11. Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)

    Time frame: 24 hours after surgery

  12. Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)

    Time frame: 2 weeks post surgery

  13. Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)

    Time frame: 6 weeks post surgery

  14. Time to Administration of First Pain Medication in PACU

    Time frame: From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)

  15. Number of Participants With Complications Related to a Study Intervention

    Time frame: 30 days

  16. Postoperative Nausea and Vomiting (PONV) Score Before Discharge

    Time frame: about 24 hours

    Postoperative Nausea and Vomiting (PONV) score before discharge

    Scale: (none, mild, moderate)

  17. Time Needed to Administer the Intervention QL Block

    Time frame: Time to administration of intervention QL block

Other outcomes

  1. Number of Participants That Required Morcellation

    Time frame: Intraoperative (about 3 hours)

  2. Specimen Weight

    Time frame: inoperative (about 3 hours)

  3. Duration of Surgery

    Time frame: about 3 hours

  4. Number of Participants That Were Discharge on the Same Day

    Time frame: Hospital discharge (up to 24 hours)

  5. Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes

    Time frame: about 3 hours

  6. Number of Participants With Intraoperative Complications

    Time frame: Intraoperative (about 3 hours)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Jun 5, 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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