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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05371015
Other study ID # 202102060A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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