Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Delivery; Quadratus Lumborum Nerve Block; Postpartum Cramping
• Intervention / Treatment: Procedure: quadratus lumborum nerve block (ropivacaine ); Procedure: quadratus lumborum nerve block (normal saline)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 33305
    • Chang Gung Memorial Hospital (Linkou)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine); The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery.	Procedure: quadratus lumborum nerve block (ropivacaine ); Echo guided quadratus lumborum nerve block with ropivacaine; Other Names: QLB
Placebo Comparator: quadratus lumborum nerve block with normal saline; The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery.	Procedure: quadratus lumborum nerve block (normal saline); Echo guided quadratus lumborum nerve block with normal saline; Other Names: QLB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale 10-item (ranging from 0 to 30, possible depression > 10)	Right before intervention
Pittsburgh sleep quality index	Pittsburgh sleep quality index (ranging from 0 to 21, where lower scores denote a healthier sleep quality)	Right before intervention
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
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
Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale 10-item (from 0 to 30, possible depression > 10)	48 hours after intervention
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
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Spasm; Muscle Cramp; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 202102060A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No