Pancreatic CarcinomaPhase 2NCT03745794
Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
A Phase 2 study testing Best Practice, Quadratus Lumborum Block and Quality-of-Life Assessment in people with Pancreatic Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- Best Practice, Quadratus Lumborum Block and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 31 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective open pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain pill).
Who cannot join
- Patients with current or past substance (drug or alcohol) abuse disorder.
- Laparoscopic or minimally invasive surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)
This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.
Read the detailed description
PRIMARY OBJECTIVE:
- To use a phase II randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum [QL] block) versus usual care (single intraoperative QL block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
ARM 2: Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
After completion of study treatment, patients are followed up at 1 month, 3 months, 6 months, and 1 year after surgery.
- Conditions
- Pancreatic Carcinoma
- Being tested
- Best Practice, Quadratus Lumborum Block, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Given standard of care
Quadratus Lumborum BlockDrug
Also called QL Block
Undergo QL block
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (QL block, standard of care) | Active comparator | Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. Receives: Other: Best Practice; Drug: Quadratus Lumborum Block; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (second QL block) | Experimental | Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care. Receives: Other: Best Practice; Drug: Quadratus Lumborum Block; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Discharged Opioid-Free
Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms
Measured: 90 days from surgery
Secondary outcomes (10)
Total Inpatient Oral Morphine Equivalents (OME)
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: Up to 1 year
Hospital Cost
Two sample t-test.
Measured: Up to 1 year
Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: Up to 1 year
Pain Prescription Dosage/Size
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: through study completion, an average of 1 year
Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: Up to 1 year
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: At 30 days after surgery
MDASI-GI in Clinic Visits
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: Up to 1 year
Percentage of Patients Using Opioids
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: At 90 days after surgery
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: At 30 and 90 days
Patients and Family Free of Opioid Use
Two sample t-test or Wilcoxon rank-sum test will be used.
Measured: At 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start28 Feb 2019
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Wei D Tzeng, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745794
- Sponsor's protocol ID
- 2018-0519
- Other IDs
- NCI-2018-02182, 2018-0519
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2018
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)
- ClinicalTrials.gov ID
- NCT03745794
- Acronym / sponsor ID
- 2018-0519
- Conditions
- Pancreatic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.
Detailed description
PRIMARY OBJECTIVE:
- To use a phase II randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum [QL] block) versus usual care (single intraoperative QL block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
ARM 2: Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
After completion of study treatment, patients are followed up at 1 month, 3 months, 6 months, and 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (QL block, standard of care) | Active comparator | Other: Best Practice, Drug: Quadratus Lumborum Block, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo QL block before surgery and receive standard of care multimodal pain control after surgery. |
| Arm II (second QL block) | Experimental | Other: Best Practice, Drug: Quadratus Lumborum Block, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective open pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain pill).
Key exclusion criteria (2 listed)
- Patients with current or past substance (drug or alcohol) abuse disorder.
- Laparoscopic or minimally invasive surgery.
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyGiven standard of care | Other | Arm I (QL block, standard of care), Arm II (second QL block) |
| Quadratus Lumborum BlockAlso: QL BlockUndergo QL block | Drug | Arm I (QL block, standard of care), Arm II (second QL block) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (QL block, standard of care), Arm II (second QL block) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (QL block, standard of care), Arm II (second QL block) |
Primary outcome
Number of Participants Discharged Opioid-Free
Time frame: 90 days from surgery
Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms
10 secondary outcomes
Total Inpatient Oral Morphine Equivalents (OME)
Time frame: Up to 1 year
Hospital Cost
Time frame: Up to 1 year
Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)
Time frame: Up to 1 year
Pain Prescription Dosage/Size
Time frame: through study completion, an average of 1 year
Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg
Time frame: Up to 1 year
Percentage of Patients Using Opioids
Time frame: At 30 days after surgery
MDASI-GI in Clinic Visits
Time frame: Up to 1 year
Percentage of Patients Using Opioids
Time frame: At 90 days after surgery
Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)
Time frame: At 30 and 90 days
Patients and Family Free of Opioid Use
Time frame: At 6 months and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Ching-Wei D Tzeng principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Quadratus Lumborum Block and Quality-of-Life Assessment in people with Pancreatic Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 23 Dec 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Discharged Opioid-Free (time frame: 90 days from surgery). 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 23 Dec 2025.