Postpartum Cramping, Quadratus Lumborum Nerve Block, Vaginal Delivery
Conditions
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.
Interventions
PROCEDUREquadratus lumborum nerve block (ropivacaine )
Echo guided quadratus lumborum nerve block with ropivacaine
PROCEDUREquadratus lumborum nerve block (normal saline)
Echo guided quadratus lumborum nerve block with normal saline
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with uterine contractions | Right before intervention | Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale | Right before intervention | Edinburgh Postnatal Depression Scale 10-item (ranging from 0 to 30, possible depression \> 10) |
| Pittsburgh sleep quality index | Right before intervention | Pittsburgh sleep quality index (ranging from 0 to 21, where lower scores denote a healthier sleep quality) |
| Modified Fatigue Symptoms Checklist | Right before intervention | Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status) |
| Postpartum Perceived Stress Scale | Right before intervention | Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress) |
Countries
Taiwan
Outcome results
None listed