Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

NCT05371015 | Completed

• 1 other identifier: 202102060A3
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quadratus Lumborum Nerve Block; Postpartum Cramping; Vaginal Delivery

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Edinburgh Postnatal Depression Scale

  Right before intervention

• Pittsburgh sleep quality index

  Right before intervention

• Modified Fatigue Symptoms Checklist

  Right before intervention

Study Arms (2)

quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine)

EXPERIMENTAL

The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery.

Procedure: quadratus lumborum nerve block (ropivacaine )

quadratus lumborum nerve block with normal saline

PLACEBO COMPARATOR

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

Procedure: quadratus lumborum nerve block (normal saline)

Interventions

quadratus lumborum nerve block (ropivacaine ) PROCEDURE

Echo guided quadratus lumborum nerve block with ropivacaine

Also known as: QLB

quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine)

quadratus lumborum nerve block (normal saline) PROCEDURE

Echo guided quadratus lumborum nerve block with normal saline

Also known as: QLB

quadratus lumborum nerve block with normal saline

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Female had maternal vaginal delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital (Linkou)

Taoyuan, 33305, Taiwan

Location

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 12, 2022
• Study Start: May 12, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 15, 2024

Record last verified: 2022-02

Locations

TW (1)