Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

Vaginal Delivery Clinical Trial

Official title:

Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05371015
• Other study ID #: 202102060A3
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Cramp
• Quadratus Lumborum Nerve Block
• Spasm
• Vaginal Delivery

Intervention

Procedure:
• quadratus lumborum nerve block (ropivacaine )
Echo guided quadratus lumborum nerve block with ropivacaine
• quadratus lumborum nerve block (normal saline)
Echo guided quadratus lumborum nerve block with normal saline

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital (Linkou)	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale 10-item (ranging from 0 to 30, possible depression > 10)	Right before intervention
Other	Pittsburgh sleep quality index	Pittsburgh sleep quality index (ranging from 0 to 21, where lower scores denote a healthier sleep quality)	Right before intervention
Other	Modified Fatigue Symptoms Checklist	Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)	Right before intervention
Other	Postpartum Perceived Stress Scale	Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)	Right before intervention
Other	Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale 10-item (from 0 to 30, possible depression > 10)	48 hours after intervention
Other	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)	48 hours after intervention
Other	Modified Fatigue Symptoms Checklist	Modified Fatigue Symptoms Checklist (ranging from 0 to 40, where higher scores mean more exhausted physical and mental status)	48 hours after intervention
Other	Postpartum Perceived Stress Scale	Postpartum Perceived Stress Scale - 14 items (range from 0 to 70 with higher scores indicating higher perceived stress)	48 hours after intervention
Primary	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)]	Right before intervention
Primary	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)]	1 hour after intervention
Primary	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)]	6 hours after intervention
Primary	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)]	12 hours after intervention
Primary	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)]	24 hours after intervention
Primary	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)]	36 hours after intervention
Primary	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)]	48 hours after intervention