| Registry | NCT05371015 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Enrollment | 66 (Actual) |
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| Sponsor | Chang Gung Memorial Hospital (Other) |
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| Conditions | Quadratus Lumborum Nerve Block, Postpartum Cramping, Vaginal Delivery |
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| Interventions | quadratus lumborum nerve block (ropivacaine ), quadratus lumborum nerve block (normal saline) (Procedure) |
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| Dates | start 2022-05-12, primary completion 2022-08-31, completion 2022-08-31, first posted 2022-05-12, last updated 2024-03-15 |
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| Locations | 1 site in Taiwan |
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All trials for Quadratus Lumborum Nerve Block All trials for Postpartum Cramping All trials of quadratus lumborum nerve block (ropivacaine ) All trials of quadratus lumborum nerve block (normal saline)
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) | Experimental | Procedure: quadratus lumborum nerve block (ropivacaine ) | The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery. |
| quadratus lumborum nerve block with normal saline | Placebo comparator | Procedure: quadratus lumborum nerve block (normal saline) | The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery. |
- quadratus lumborum nerve block (ropivacaine ) (Procedure), also known as QLB: Echo guided quadratus lumborum nerve block with ropivacaine
- quadratus lumborum nerve block (normal saline) (Procedure), also known as QLB: Echo guided quadratus lumborum nerve block with normal saline
+Outcome measures
Primary outcomes
- 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 \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [1 hour after intervention]: Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [6 hours after intervention]: Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [12 hours after intervention]: Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [24 hours after intervention]: Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [36 hours after intervention]: Grading with Numerical Pain Scale \[0 (no pain at all) to 10 (worst imaginable pain)\] and Visual Analogue Scale \[mark a position between 0 (no pain at all) to 10 (worst imaginable pain)\]
- Pain associated with uterine contractions [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
- 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)
- Edinburgh Postnatal Depression Scale [48 hours after intervention]: Edinburgh Postnatal Depression Scale 10-item (from 0 to 30, possible depression > 10)
- Pittsburgh sleep quality index [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)
- Modified Fatigue Symptoms Checklist [48 hours after intervention]: Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)
- Postpartum Perceived Stress Scale [48 hours after intervention]: Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)
+Eligibility
Sex: Female, ages: 20 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Chang Gung Memorial Hospital (Linkou) | Taoyuan City | Taiwan | |
+Publications
- Results publication: Cheng WS, Chen YT, Chao WH, Liao CC. Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Normal Spontaneous Delivery: A Prospective, Randomized, Double-Blind, Controlled Trial. Health Sci Rep. 2026 May 31;9(6):e72586. doi: 10.1002/hsr2.72586. eCollection 2026 Jun. PMID 42255090