Pain, PostoperativeNCT05005871
Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain
A study testing Quadratus lumborum block after C-section surgery as postoperative pain management in people with Pain, Postoperative and Pain, Acute, run by Udayana University at 1 site in Indonesia.
Trial summary
Acute pain is reported in approximately 80% of patients undergoing postoperative care for various types of surgical procedures in the United States. Another study reported patient postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days and 38% reporting moderate to severe pain at… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Cesarean Section Complications
- What is being tested?
- Quadratus lumborum block after C-section surgery as postoperative pain management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2021to 14 Oct 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Underwent C-section with subarachnoid block
- Aged 18-35 years old.
- ASA preoperative physical status 1-2
Who cannot join
- Coagulopathy
- Anatomic abnormalities of the abdomen
- History of allergy to local anesthesia
- History of hyperalgesia
- History of drug abuse (sedatives, opioids, paracetamol, or other pain relievers)
- Require postoperative intensive care
- Refuse to participate in research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain
Acute pain is reported in approximately 80% of patients undergoing postoperative care for various types of surgical procedures in the United States. Another study reported patient postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days and 38% reporting moderate to severe pain at 14 postoperative days. Several modalities have been used as the standard for the management of pain postoperative C-sections.
One of the postoperative analgesic modalities for SC is quadratus lumborum block (QLB). This technique has advantages in relieving postoperative pain after C-section because it is considered to be able to relieve visceral pain as well as somatic pain. The transmuscular QLB (QLBT) approach is one of the most frequently used. This technique was found to be effective with regard to the distribution of analgesics to the paravertebral spaces which is the hallmark of QLB. However, this technique was found to be difficult to perform. Difficulties were reported related to the position of the procedure i.e. lateral or sitting position.
- Being tested
- Quadratus lumborum block after C-section surgery as postoperative pain management
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum block after C-section surgery as postoperative pain managementOther
To manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum intramuscular block | Active comparator | The quadratus lumborum intramuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists. Receives: Other: Quadratus lumborum block after C-section surgery as postoperative pain management |
| Quadratus lumborum transmucular block | Active comparator | The quadratus lumborum transmuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists. Receives: Other: Quadratus lumborum block after C-section surgery as postoperative pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Measured: Up to 24 hours after surgery
Postoperative morphine requirements
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
Measured: Up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Sep 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005871
- Sponsor's protocol ID
- UNUD-CTR-FK150621-001
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Intramuscular and Transmucular Quadratus Lumborum Blocks Quality in Postoperative Pain
- ClinicalTrials.gov ID
- NCT05005871
- Acronym / sponsor ID
- UNUD-CTR-FK150621-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 16 Aug 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.
Acute pain is reported in approximately 80% of patients undergoing postoperative care for various types of surgical procedures in the United States. Another study reported patient postoperative pain intensity with 75% with severe pain in the first 1 to 2 postoperative days and 38% reporting moderate to severe pain at 14 postoperative days. Several modalities have been used as the standard for the management of pain postoperative C-sections.
One of the postoperative analgesic modalities for SC is quadratus lumborum block (QLB). This technique has advantages in relieving postoperative pain after C-section because it is considered to be able to relieve visceral pain as well as somatic pain. The transmuscular QLB (QLBT) approach is one of the most frequently used. This technique was found to be effective with regard to the distribution of analgesics to the paravertebral spaces which is the hallmark of QLB. However, this technique was found to be difficult to perform. Difficulties were reported related to the position of the procedure i.e. lateral or sitting position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum intramuscular block | Active comparator | Other: Quadratus lumborum block after C-section surgery as postoperative pain managementThe quadratus lumborum intramuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists. |
| Quadratus lumborum transmucular block | Active comparator | Other: Quadratus lumborum block after C-section surgery as postoperative pain managementThe quadratus lumborum transmuscular block will be performed immediately at the end of the surgery. Administration of 0.4 mL of 0.25% bupivacaine will be carried out under ultrasound guidance and performed by experienced anesthesiologists. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Underwent C-section with subarachnoid block
- Aged 18-35 years old.
- ASA preoperative physical status 1-2
Key exclusion criteria (7 listed)
- Coagulopathy
- Anatomic abnormalities of the abdomen
- History of allergy to local anesthesia
- History of hyperalgesia
- History of drug abuse (sedatives, opioids, paracetamol, or other pain relievers)
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 block after C-section surgery as postoperative pain managementTo manage postoperative pain, the subjects will be allocated to either QLB or QLTB group to receive the respective intervention. | Other | Quadratus lumborum intramuscular block, Quadratus lumborum transmucular block |
Primary outcome
Postoperative pain
Time frame: Up to 24 hours after surgery
Postoperative pain intensity measured by Visual Analog Scale (VAS), 0=no pain, 100=worst pain
Postoperative morphine requirements
Time frame: Up to 72 hours after surgery
Total delivered morphine dose after surgery to alleviate postoperative pain (measured by total delivered dose recorded on the Patient-Controlled Analgesia tool)
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 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Postoperative
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.
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 after C-section surgery as postoperative pain management in people with Pain, Postoperative and Pain, Acute, run by Udayana University at 1 site in Indonesia.
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 3 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 19 Oct 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 Indonesia. 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?
Postoperative pain (time frame: Up to 24 hours after surgery). The study lists 2 primary outcomes in all. 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 19 Oct 2021.