Postoperative PainPhase 4NCT02691403
Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure
A Phase 4 study testing levo-bupivacaine and normal saline in people with Postoperative Pain, run by Sun Yat-sen University.
Trial summary
Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- levo-bupivacaine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2017
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A physical status between ASA I and III
- 20 - 75 years of age
- Patient has signed an informed consent
- Without contraindication of QL block
Who cannot join
- American Society of Anesthesiologists (ASA) Physical Status ≥ 4
- Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
- Severe obesity (body mass index≥ 35 kg/m2)
- Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
- Allergy to NSAIDs
- Infection at the QL injection site
- Patients with major psychosis or drug and alcohol abuse
- Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump
About this study
Official title: Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial
Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.
- Conditions
- Postoperative Pain
- Being tested
- levo-bupivacaine, normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levo-bupivacaineDrug
normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo QL block | Sham comparator | 30 ml single shot QL block with saline 0.9% Receives: Drug: normal saline |
| Active QL block | Active comparator | 30 ml single shot QL block with 0.25% levo-bupivacaine Receives: Drug: levo-bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nai Liang Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691403
- Sponsor's protocol ID
- QLCO
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02691403
- Acronym / sponsor ID
- QLCO
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- 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.
Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo QL block | Sham comparator | Drug: normal saline30 ml single shot QL block with saline 0.9% |
| Active QL block | Active comparator | Drug: levo-bupivacaine30 ml single shot QL block with 0.25% levo-bupivacaine |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A physical status between ASA I and III
- 20 - 75 years of age
- Patient has signed an informed consent
- Without contraindication of QL block
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) Physical Status ≥ 4
- Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
- Severe obesity (body mass index≥ 35 kg/m2)
- Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
- Allergy to NSAIDs
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 |
|---|---|---|
| levo-bupivacaine | Drug | Active QL block |
| normal saline | Drug | Placebo QL block |
Primary outcome
cumulative morphine consumption
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levo-bupivacaine and normal saline in people with Postoperative Pain, run by Sun Yat-sen University.
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 8 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cumulative morphine consumption (time frame: 1 hour). 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 25 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.