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Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

Primary Purpose

Quadratus Lumborum Nerve Block, Postpartum Cramping, Vaginal Delivery

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
quadratus lumborum nerve block (ropivacaine )
quadratus lumborum nerve block (normal saline)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quadratus Lumborum Nerve Block

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital (Linkou)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

quadratus lumborum nerve block with normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)]
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)]
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)]
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)]
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)]
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)]
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)]

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
February 21, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05371015
Brief Title
Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth
Official Title
Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Nerve Block, Postpartum Cramping, Vaginal Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty subjects were randomly assigned to the quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine), and another 50 subjects were assigned to the quadratus lumborum nerve block with normal saline injection. The total number of subjects involved is one hundred.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
After the computer program (SAS® 9.4) generates the groups of subjects in random order, a third-party person who is not the research team will put the groups into envelopes numbered one to one hundred in sequence. Which group the subjects will be assigned to will not be known to members of the research team until the trial is unblinded.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine)
Arm Type
Experimental
Arm Description
The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery.
Arm Title
quadratus lumborum nerve block with normal saline
Arm Type
Placebo Comparator
Arm Description
The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery.
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum nerve block (ropivacaine )
Other Intervention Name(s)
QLB
Intervention Description
Echo guided quadratus lumborum nerve block with ropivacaine
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum nerve block (normal saline)
Other Intervention Name(s)
QLB
Intervention Description
Echo guided quadratus lumborum nerve block with normal saline
Primary Outcome Measure Information:
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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
Title
Pain associated with uterine contractions
Description
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 Pre-specified Outcome Measures:
Title
Edinburgh Postnatal Depression Scale
Description
Edinburgh Postnatal Depression Scale 10-item (ranging from 0 to 30, possible depression > 10)
Time Frame
Right before intervention
Title
Pittsburgh sleep quality index
Description
Pittsburgh sleep quality index (ranging from 0 to 21, where lower scores denote a healthier sleep quality)
Time Frame
Right before intervention
Title
Modified Fatigue Symptoms Checklist
Description
Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)
Time Frame
Right before intervention
Title
Postpartum Perceived Stress Scale
Description
Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)
Time Frame
Right before intervention
Title
Edinburgh Postnatal Depression Scale
Description
Edinburgh Postnatal Depression Scale 10-item (from 0 to 30, possible depression > 10)
Time Frame
48 hours after intervention
Title
Pittsburgh sleep quality index
Description
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
Title
Modified Fatigue Symptoms Checklist
Description
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
Title
Postpartum Perceived Stress Scale
Description
Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)
Time Frame
48 hours after intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female had maternal vaginal delivery
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital (Linkou)
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

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Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

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