Anesthesia, ObstetricalNCT03333902
The Comparison Of Nerve Blocks In Cesarean Delivery
A study testing QLB in people with Anesthesia, Obstetrical, run by Feng Xia at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia. Read more about this study
- Who is it for?
- Ages 24 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Obstetrical
- What is being tested?
- QLB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 30 Aug 2018
- 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 24 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- weight from 50 to 70 kilogrammes
- a normal singleton pregnancy
- ≥37 weeks gestation
Who cannot join
- congenital coagulopathy
- anatomic abnormalities
- localized skin infection
- allergy to any of the drugs used
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial
The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.
Read the detailed description
Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.
- Conditions
- Anesthesia, Obstetrical
- Being tested
- QLB, Intravenous patient controlled analgesia (PCA)
- Keywords
- quadratus lumborum block, anesthesia, pain, postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLBProcedure or surgery
QLB, quadratus lumborum block.
Intravenous patient controlled analgesia (PCA)Procedure or surgery
Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
| Study group | Role | What they receive |
|---|---|---|
| QLB type 2 | Experimental | Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.
Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. Receives: Procedure: QLB; Procedure: Intravenous patient controlled analgesia (PCA) |
| QLB type 3 | Experimental | Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.
Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. Receives: Procedure: QLB; Procedure: Intravenous patient controlled analgesia (PCA) |
| QLB type 2+3 | Experimental | Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL.
Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. Receives: Procedure: QLB; Procedure: Intravenous patient controlled analgesia (PCA) |
| epidural anesthesia group (EA) | Active comparator | Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether.
Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. Receives: Procedure: QLB; Procedure: Intravenous patient controlled analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change trend of Visual Analogue Scale (VAS) at rest and movement
The purpose is to view the change of the level of pain assessed by subjects at adjacent time points. We would set 0, 4, 6, 12, 24, 48 hours postoperatively as observational time points.
Measured: 0-48 hours postoperatively
Secondary outcomes (2)
total morphine consumption
total morphine consumption
Measured: 0-48 hours postoperatively
complications
nausea, vomiting, retention of urine, lower limb weakness, etc.
Measured: 0-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Jun 2018
- Study completion30 Aug 2018
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 Anesthesia, ObstetricalStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333902
- Sponsor's protocol ID
- [2016]123
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03333902
- Acronym / sponsor ID
- [2016]123
- Conditions
- Anesthesia, Obstetrical
- Keywords
- quadratus lumborum block, anesthesia, pain, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Feng XiaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 7 Nov 2017 (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 investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.
Detailed description
Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLB type 2 | Experimental | Procedure: QLB, Procedure: Intravenous patient controlled analgesia (PCA)Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. |
| QLB type 3 | Experimental | Procedure: QLB, Procedure: Intravenous patient controlled analgesia (PCA)Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. |
| QLB type 2+3 | Experimental | Procedure: QLB, Procedure: Intravenous patient controlled analgesia (PCA)Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. |
| epidural anesthesia group (EA) | Active comparator | Procedure: QLB, Procedure: Intravenous patient controlled analgesia (PCA)Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours. |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- weight from 50 to 70 kilogrammes
- a normal singleton pregnancy
- ≥37 weeks gestation
Key exclusion criteria (4 listed)
- congenital coagulopathy
- anatomic abnormalities
- localized skin infection
- allergy to any of the drugs used
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 |
|---|---|---|
| QLBQLB, quadratus lumborum block. | Procedure or surgery | QLB type 2, QLB type 2+3, QLB type 3, epidural anesthesia group (EA) |
| Intravenous patient controlled analgesia (PCA)Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally. | Procedure or surgery | QLB type 2, QLB type 2+3, QLB type 3, epidural anesthesia group (EA) |
Primary outcome
the change trend of Visual Analogue Scale (VAS) at rest and movement
Time frame: 0-48 hours postoperatively
The purpose is to view the change of the level of pain assessed by subjects at adjacent time points. We would set 0, 4, 6, 12, 24, 48 hours postoperatively as observational time points.
2 secondary outcomes
total morphine consumption
Time frame: 0-48 hours postoperatively
complications
Time frame: 0-48 hours postoperatively
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 24 Jan 2019.
- Background: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Individual participant dataSharing planned: No
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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 QLB in people with Anesthesia, Obstetrical, run by Feng Xia 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 4 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 24 Jan 2019. 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?
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?
the change trend of Visual Analogue Scale (VAS) at rest and movement (time frame: 0-48 hours postoperatively). 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 NCT03333902, 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 24 Jan 2019.