Quadratus Lumborum Nerve BlockNCT05371015
Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth
A study testing quadratus lumborum nerve block (ropivacaine ) and quadratus lumborum nerve block (normal saline) in people with Quadratus Lumborum Nerve Block and Postpartum Cramping, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Quadratus Lumborum Nerve Block, Postpartum Cramping, Vaginal Delivery
- What is being tested?
- quadratus lumborum nerve block (ropivacaine ) and quadratus lumborum nerve block (normal saline)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- quadratus lumborum nerve block (ropivacaine ), quadratus lumborum nerve block (normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadratus lumborum nerve block (ropivacaine )Procedure or surgery
Also called QLB
Echo guided quadratus lumborum nerve block with ropivacaine
quadratus lumborum nerve block (normal saline)Procedure or surgery
Also called QLB
Echo guided quadratus lumborum nerve block with normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: quadratus lumborum nerve block (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 48 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start12 May 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quadratus Lumborum Nerve BlockStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371015
- Sponsor's protocol ID
- 202102060A3
- Status last verified
- Feb 2022
- First submitted
- 5 Apr 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng WS, Chen YT, Chao WH, Liao CC. Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Normal Spontaneous Delivery: A Prospective, Randomized, Double-Blind, Controlled Trial. Health Sci Rep. 2026 May 31;9(6):e72586. doi: 10.1002/hsr2.72586. eCollection 2026 Jun.
PubMed 42255090
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth
- ClinicalTrials.gov ID
- NCT05371015
- Acronym / sponsor ID
- 202102060A3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) | Experimental | Procedure: quadratus lumborum nerve block (ropivacaine )The subjects would have quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) after vaginal delivery. |
| quadratus lumborum nerve block with normal saline | Placebo comparator | Procedure: quadratus lumborum nerve block (normal saline)The subjects would have quadratus lumborum nerve block with normal saline after vaginal delivery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quadratus lumborum nerve block (ropivacaine )Also: QLBEcho guided quadratus lumborum nerve block with ropivacaine | Procedure or surgery | quadratus lumborum nerve block group with injection of local anesthetic (Ropivacaine) |
| quadratus lumborum nerve block (normal saline)Also: QLBEcho guided quadratus lumborum nerve block with normal saline | Procedure or surgery | quadratus lumborum nerve block with normal saline |
Primary outcome
Pain associated with uterine contractions
Time frame: Right before intervention
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)]
Pain associated with uterine contractions
Time frame: 1 hour after intervention
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)]
Pain associated with uterine contractions
Time frame: 6 hours after intervention
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)]
Pain associated with uterine contractions
Time frame: 12 hours after intervention
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)]
Pain associated with uterine contractions
Time frame: 24 hours after intervention
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)]
Pain associated with uterine contractions
Time frame: 36 hours after intervention
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)]
Pain associated with uterine contractions
Time frame: 48 hours after intervention
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 42255090Cheng WS, Chen YT, Chao WH, Liao CC. Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Normal Spontaneous Delivery: A Prospective, Randomized, Double-Blind, Controlled Trial. Health Sci Rep. 2026 May 31;9(6):e72586. doi: 10.1002/hsr2.72586. eCollection 2026 Jun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quadratus lumborum nerve block (ropivacaine ) and quadratus lumborum nerve block (normal saline) in people with Quadratus Lumborum Nerve Block and Postpartum Cramping, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain associated with uterine contractions (time frame: Right before intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.