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Completed

NCT Number: NCT05371015

Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

With the continuous advancement of ultrasonic technology, nerve block in which drugs are injected into the periphery of the target nerve through ultrasonic guidance has become the mainstream method for postoperative pain control. The quadratus lumborum nerve block has been effectively and safely used in abdominal surgery (such as laparotomy, caesarean section, etc.), effectively reducing postoperative wounds and visceral pain. There is no research on the use of quadratus lumborum nerve block to control the pain of natural postpartum uterine contractions in the current literature, so the purpose of this experiment is to explore whether the quadratus lumborum nerve block can effectively reduce the pain of uterine contractions after vaginal delivery.

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Key information

Conditions

Quadratus Lumborum Nerve Block Postpartum Cramping Vaginal Delivery

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital (Linkou)

Taoyuan City, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females over twenty years of age
  • Maternal vaginal delivery
  • Postpartum moderate to severe pain with uterine contractions (Numerical Pain Scale (NRS) ≥ 4 points) after delivery.
  • Subject's consent signed by the subject

Exclusion criteria

  • Severe coagulation abnormalities (PLT<100000、INR>1.2、PT>13)
  • Infection of the epidermis at the anticipated relevant site of injection
  • Allergy to local anesthetics
  • Allergy to or abuse of pain control medications
  • Episiotomy is more painful than uterine contractions
  • Inability to cooperate with associated pain assessment
  • Body Mass Index (BMI) ≧ 35 kg/m2

Treatment and study plan

quadratus lumborum nerve block (ropivacaine )

Procedure

Echo guided quadratus lumborum nerve block with ropivacaine

Other names: QLB

quadratus lumborum nerve block (normal saline)

Procedure

Echo guided quadratus lumborum nerve block with normal saline

Other names: QLB

Primary outcomes

  1. Pain associated with uterine contractions

    Time frame: Right before intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  2. Pain associated with uterine contractions

    Time frame: 1 hour after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  3. Pain associated with uterine contractions

    Time frame: 6 hours after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  4. Pain associated with uterine contractions

    Time frame: 12 hours after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  5. Pain associated with uterine contractions

    Time frame: 24 hours after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  6. Pain associated with uterine contractions

    Time frame: 36 hours after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

  7. Pain associated with uterine contractions

    Time frame: 48 hours after intervention

    Grading with Numerical Pain Scale [0 (no pain at all) to 10 (worst imaginable pain)] and Visual Analogue Scale [mark a position between 0 (no pain at all) to 10 (worst imaginable pain)]

Other outcomes

  1. Edinburgh Postnatal Depression Scale

    Time frame: Right before intervention

    Edinburgh Postnatal Depression Scale 10-item (ranging from 0 to 30, possible depression > 10)

  2. Pittsburgh sleep quality index

    Time frame: Right before intervention

    Pittsburgh sleep quality index (ranging from 0 to 21, where lower scores denote a healthier sleep quality)

  3. Modified Fatigue Symptoms Checklist

    Time frame: Right before intervention

    Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)

  4. Postpartum Perceived Stress Scale

    Time frame: Right before intervention

    Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)

  5. Edinburgh Postnatal Depression Scale

    Time frame: 48 hours after intervention

    Edinburgh Postnatal Depression Scale 10-item (from 0 to 30, possible depression > 10)

  6. Pittsburgh sleep quality index

    Time frame: 48 hours after intervention

    Pittsburgh sleep quality index Modified Fatigue Symptoms Checklis (ranging from 0 to 21, where lower scores denote a healthier sleep quality)

  7. Modified Fatigue Symptoms Checklist

    Time frame: 48 hours after intervention

    Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)

  8. Postpartum Perceived Stress Scale

    Time frame: 48 hours after intervention

    Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Mar 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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