Quadratus Lumborum BlockNCT04822870
Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section
A study testing quadratus lumborum block, iliohypogastric/ilioinguinal nerve block and epidural analgesia in people with Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quadratus Lumborum Block, Iliohypogastric/Ilioinguinal Nerve Block, Cesarean Section
- What is being tested?
- quadratus lumborum block, iliohypogastric/ilioinguinal nerve block and epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2021to May 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton pregnancy
- gestation of at least 37 weeks
- American Society of Anesthesiologists (ASA) physical status I or II
- finish Pfannenstiel section under combined spinal and epidural anesthesia
Who cannot join
- pruritus existed before the surgery
- allergic to lidocaine, ropivacaine or dexamethasone
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section: a Randomized Double-blind Clinical Trial Study
The purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.
- Being tested
- quadratus lumborum block, iliohypogastric/ilioinguinal nerve block, epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadratus lumborum blockProcedure or surgery
Quadratus lumborum block is an effective nerve block method in post-cesarean section analgesia. It is a relatively new technique that may provide analgesic effect in somatic pain and visceral pain, but has not been verified yet.
iliohypogastric/ilioinguinal nerve blockProcedure or surgery
Iliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section.
epidural analgesiaProcedure or surgery
Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum block | Experimental | Parturients receive ultrasound-guided quadratus lumborum block as post-operative analgesia. Receives: Procedure: quadratus lumborum block |
| iliohypogastric/ilioinguinal nerve block | Experimental | Parturients receive ultrasound-guided iliohypogastric/ilioinguinal nerve block as post-operative analgesia. Receives: Procedure: iliohypogastric/ilioinguinal nerve block |
| epidural analgesia | Active comparator | Parturients receive epidural morphine via epidural catheter placed during anesthesia as post-operative analgesia. Receives: Procedure: epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Measured: 24 hours postoperatively
Secondary outcomes (15)
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Measured: 6 hours postoperatively
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Measured: 12 hours postoperatively
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Measured: 48 hours postoperatively
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Measured: 6 hours postoperatively
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Measured: 12 hours postoperatively
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Measured: 24 hours postoperatively
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Measured: 48 hours postoperatively
effective analgesia time
Time period between finish the intervention and the first time parturient use the patient-controlled intravenous analgesia pump for analgesia supplement.
Measured: 48 hours postoperatively
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Measured: 6 hours postoperatively
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Measured: 12 hours postoperatively
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Measured: 24 hours postoperatively
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Measured: 48 hours postoperatively
satisfaction score
Ask the patient to evaluate satisfaction score using 0-10. 0 refers totally dissatisfied, 10 refers to the most satisfied
Measured: 48 hours postoperatively
hospital stay
The hospitalize length
Measured: at discharge assessed up to 10 days
hospitalize cost
Total cost in this hospitalization
Measured: at discharge assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start31 Mar 2021
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum BlockStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822870
- Sponsor's protocol ID
- 2021-Z-01
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section: a Randomized Double-blind Clinical Trial Study
- ClinicalTrials.gov ID
- NCT04822870
- Acronym / sponsor ID
- 2021-Z-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 30 Mar 2021 (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.
The purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum block | Experimental | Procedure: quadratus lumborum blockParturients receive ultrasound-guided quadratus lumborum block as post-operative analgesia. |
| iliohypogastric/ilioinguinal nerve block | Experimental | Procedure: iliohypogastric/ilioinguinal nerve blockParturients receive ultrasound-guided iliohypogastric/ilioinguinal nerve block as post-operative analgesia. |
| epidural analgesia | Active comparator | Procedure: epidural analgesiaParturients receive epidural morphine via epidural catheter placed during anesthesia as post-operative analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- gestation of at least 37 weeks
- American Society of Anesthesiologists (ASA) physical status I or II
- finish Pfannenstiel section under combined spinal and epidural anesthesia
Key exclusion criteria (2 listed)
- pruritus existed before the surgery
- allergic to lidocaine, ropivacaine or dexamethasone
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 blockQuadratus lumborum block is an effective nerve block method in post-cesarean section analgesia. It is a relatively new technique that may provide analgesic effect in somatic pain and visceral pain, but has not been verified yet. | Procedure or surgery | quadratus lumborum block |
| iliohypogastric/ilioinguinal nerve blockIliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section. | Procedure or surgery | iliohypogastric/ilioinguinal nerve block |
| epidural analgesiaEpidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect. | Procedure or surgery | epidural analgesia |
Primary outcome
morphine consumption
Time frame: 24 hours postoperatively
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
15 secondary outcomes
morphine consumption
Time frame: 6 hours postoperatively
morphine consumption
Time frame: 12 hours postoperatively
morphine consumption
Time frame: 48 hours postoperatively
pain score
Time frame: 6 hours postoperatively
pain score
Time frame: 12 hours postoperatively
pain score
Time frame: 24 hours postoperatively
pain score
Time frame: 48 hours postoperatively
effective analgesia time
Time frame: 48 hours postoperatively
adverse effect
Time frame: 6 hours postoperatively
adverse effect
Time frame: 12 hours postoperatively
adverse effect
Time frame: 24 hours postoperatively
adverse effect
Time frame: 48 hours postoperatively
satisfaction score
Time frame: 48 hours postoperatively
hospital stay
Time frame: at discharge assessed up to 10 days
hospitalize cost
Time frame: at discharge assessed up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
Yi Feng, MD study chair
Peking University People's Hospital
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 block, iliohypogastric/ilioinguinal nerve block and epidural analgesia in people with Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block, run by Peking University People's Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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 China. 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. 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?
Results are not available in the source record.
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?
morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2021.