Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

NCT ID: NCT05371015

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Quadratus Lumborum Nerve Block Postpartum Cramping Vaginal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

quadratus lumborum nerve block (ropivacaine )

Intervention Type PROCEDURE

Echo guided quadratus lumborum nerve block with ropivacaine

quadratus lumborum nerve block with normal saline

The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery.

Group Type PLACEBO_COMPARATOR

quadratus lumborum nerve block (normal saline)

Intervention Type PROCEDURE

Echo guided quadratus lumborum nerve block with normal saline

Interventions

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quadratus lumborum nerve block (ropivacaine )

Echo guided quadratus lumborum nerve block with ropivacaine

Intervention Type PROCEDURE

quadratus lumborum nerve block (normal saline)

Echo guided quadratus lumborum nerve block with normal saline

Intervention Type PROCEDURE

Other Intervention Names

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QLB QLB

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital (Linkou)

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202102060A3

Identifier Type: -

Identifier Source: org_study_id

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