CClinicalTrials.gg
CompletedNCT05371015Updated Mar 15, 2024

Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

An interventional study of quadratus lumborum nerve block (ropivacaine ) and quadratus lumborum nerve block (normal saline) in Quadratus Lumborum Nerve Block, Postpartum Cramping and Vaginal Delivery, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Quadratus Lumborum Nerve Block
  • Postpartum Cramping
  • Vaginal Delivery

Browse trials for

03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine)

    The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery.

    Procedure: quadratus lumborum nerve block (ropivacaine )

  • Placebo comparator
    quadratus lumborum nerve block with normal saline

    The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery.

    Procedure: quadratus lumborum nerve block (normal saline)

Interventions

  • Procedurequadratus lumborum nerve block (ropivacaine )

    Echo guided quadratus lumborum nerve block with ropivacaine

    Also known as: QLB

  • Procedurequadratus lumborum nerve block (normal saline)

    Echo guided quadratus lumborum nerve block with normal saline

    Also known as: QLB

05

What researchers measure

Primary outcomes

  1. Pain associated with uterine contractions

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

    Time frame: Right before intervention

  2. Pain associated with uterine contractions

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

    Time frame: 1 hour after intervention

  3. Pain associated with uterine contractions

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

    Time frame: 6 hours after intervention

  4. Pain associated with uterine contractions

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

    Time frame: 12 hours after intervention

  5. Pain associated with uterine contractions

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

    Time frame: 24 hours after intervention

  6. Pain associated with uterine contractions

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

    Time frame: 36 hours after intervention

  7. Pain associated with uterine contractions

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

    Time frame: 48 hours after intervention

Other outcomes

  1. Edinburgh Postnatal Depression Scale

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

    Time frame: Right before intervention

  2. Pittsburgh sleep quality index

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

    Time frame: Right before intervention

  3. Modified Fatigue Symptoms Checklist

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

    Time frame: Right before intervention

  4. Postpartum Perceived Stress Scale

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

    Time frame: Right before intervention

  5. Edinburgh Postnatal Depression Scale

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

    Time frame: 48 hours after intervention

  6. Pittsburgh sleep quality index

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

    Time frame: 48 hours after intervention

  7. Modified Fatigue Symptoms Checklist

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

    Time frame: 48 hours after intervention

  8. Postpartum Perceived Stress Scale

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

    Time frame: 48 hours after intervention

06

Study locations

1 site
  • Chang Gung Memorial Hospital (Linkou)
    Taoyuan City, 33305, Taiwan
07

Registry details

Key details

Study ID
NCT05371015
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
May 12, 2022
Start date
May 12, 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Mar 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion