Clinical trial NCT05371015: 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
Overall status: COMPLETED
Phase: NA
Conditions: Quadratus Lumborum Nerve Block
Postpartum Cramping
Vaginal Delivery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain associated with uterine contractions
timeFrame: Right before intervention
measure: Pain associated with uterine contractions
timeFrame: 1 hour after intervention
measure: Pain associated with uterine contractions
timeFrame: 6 hours after intervention
measure: Pain associated with uterine contractions
timeFrame: 12 hours after intervention
measure: Pain associated with uterine contractions
timeFrame: 24 hours after intervention
measure: Pain associated with uterine contractions
timeFrame: 36 hours after intervention
measure: Pain associated with uterine contractions
timeFrame: 48 hours after intervention
Secondary outcomes:
Other outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: Right before intervention
measure: Pittsburgh sleep quality index
timeFrame: Right before intervention
measure: Modified Fatigue Symptoms Checklist
timeFrame: Right before intervention
measure: Postpartum Perceived Stress Scale
timeFrame: Right before intervention
measure: Edinburgh Postnatal Depression Scale
timeFrame: 48 hours after intervention
measure: Pittsburgh sleep quality index
timeFrame: 48 hours after intervention
measure: Modified Fatigue Symptoms Checklist
timeFrame: 48 hours after intervention
measure: Postpartum Perceived Stress Scale
timeFrame: 48 hours after intervention
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital (Linkou)
Study officials:
References: