Perioperative Opioid Sparing TechniquesNCT07153614
Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy
A study testing Intrathecal Morphine Block, Bilateral Quadratus Lumborum Block and Bilateral Transverse Abdominis Plane Block in people with Perioperative Opioid Sparing Techniques, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if intrathecal morphine (ITM) administration is superior to quadratus lumborum block or surgeon administered transversus abdominis plane (TAP) blocks result in decreased time to initiation of chemotherapy following oncologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perioperative Opioid Sparing Techniques
- What is being tested?
- Intrathecal Morphine Block, Bilateral Quadratus Lumborum Block and Bilateral Transverse Abdominis Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 3 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- Patients undergoing open surgery for foregut, HPB, and colorectal cancer
- Able to read and understand study procedures
- Willing to participate and sign an ICF
- If female of childbearing potential, subject must have a negative pregnancy test
- Recommended for adjuvant chemotherapy
Show all 9Show fewer
- Patients scheduled for an AM admit procedure
- English speaking
- Patients with a midline incision
Who cannot join
- Chronic Opioid Use (received an opioid within 90 days preoperatively)
- Recreational Drug Use
- Patients with cognitive impairments that can affect their ability to give consent
- Patients that are currently taking anti-coagulants <7 days prior to surgery
- Pregnant or breastfeeding
- Does not require adjuvant chemotherapy
Show all 18Show fewer
- Relative Contradictions for receiving a nerve block*
- Patients that have been admitted prior to surgery for chief complaint related to complications from malignancy
- Inability to provide consent
- Absolute Contraindications
- Lack of patient consent.
- Skin infection at the site of needle insertion. Relative Contraindications
- Coagulopathy
- Systemic infection
- Anatomical distortion
- Neuropathy
- Drugs/Device usage within 7 Days of Randomization if any:
- Anticoagulants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
Study Coordinator: Lauren Crawford, MS, 865-305-9308, lcrawford@utmck.edu
Che A. Solla MD, MBA
About this study
Official title: Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study
The primary purpose of this study is to determine if intrathecal morphine (ITM) administration is superior to quadratus lumborum block or surgeon administered transversus abdominis plane (TAP) blocks result in decreased time to initiation of chemotherapy following oncologic surgery.
The secondary objectives of this study are to determine:
Read more
- The difference between interventions in time to return of bowel function in days
- The difference between interventions in incidence of opioid related adverse drug events (ORADEs)
- The difference between interventions in cumulative and post-operative total morphine milligram equivalents
- The difference between interventions in quality-of-life assessment tool and patient satisfaction (brief pain index short form BPI-sf9)
- The difference between interventions in hospital length of stay in days
- The difference between cumulative pain scores between interventions
- The difference between short acting and long-acting bupivacaine in pain management and time to chemotherapy
The hypothesis is that preoperative intrathecal morphine administration will significantly reduce the time to initiation of postoperative chemotherapy.
Read the detailed description
Enhanced recovery after surgery (ERAS) has become the standard of perioperative care for patients undergoing oncologic surgery. Multimodal and regional anesthetic techniques to reduce postoperative pain and opioid requirements are a key component of ERAS. Epidural analgesia was considered standard in early ERAS protocols. however, it is labor-intensive, requires close postoperative follow-up, and may exacerbate hemodynamic instability.
Long-acting intrathecal (IT) opioid use in oncologic surgery has been described as an equianalgesic technique to epidural analgesia with an improved safety profile, although both have the potential for neurological complications and respiratory depression9. Quadratus lumborum (QL) block is an alternative opioid sparing technique to neuraxial analgesia for abdominal surgery. QL blocks can provide similar pain coverage as an epidural with decreased hemodynamic instability. However, it is limited by its relatively short duration of effect, which ranges from 6 to 12 h. Another method employed is the transversus abdominis plane block. One of the advantages of this technique is that it does not depend on a separate service to perform like ITM and QL as it is commonly performed by the surgeon during surgery. However, unlike the QL block which has been shown to spread to the lumbar plexus and even thoracic paravertebral space providing both somatic and visceral analgesia, TAP blocks only provide somatic analgesia coverage. TAP blocks are still frequently performed by oncologic surgeons though the long term success compared to QL and ITM blocks is unclear. Most research looking into the efficacy of these techniques has been aimed at studying their effects on pain scores, opioid requirements, and opioid related adverse drug events.
Time to initiation of adjuvant chemotherapy (AC) following oncologic surgery is an important predictor of survivability that has not yet been considered in QL vs. IT comparison studies. Two meta-analyses demonstrated that postponing the postoperative AC was associated with poor survival in colorectal cancer patients. Results from Biagi et al. showed that every 4 weeks delay result in a 14% decrease of overall survival (OS). Similarly, Guetz's study indicated that delaying the initiation of AC for > 8 weeks after operation significantly decreased OS. In pancreatic and colorectal cancer, several factors are involved in this metric. One of the more common factors in this patient population is gastrointestinal complications including ileus. Some of these complications can be affected by perioperative opioid consumption.
- Conditions
- Perioperative Opioid Sparing Techniques
- Being tested
- Intrathecal Morphine Block, Bilateral Quadratus Lumborum Block, Bilateral Transverse Abdominis Plane Block
- Keywords
- Opioid, Perioperative Opioid Sparing Techniques, Colorectal Cancer, Foregut Cancer, Hepatopancreatobiliary (HPB)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Morphine BlockProcedure or surgery
Morphine 150 mcg
Bilateral Quadratus Lumborum BlockProcedure or surgery
30 mL of 0.25% bupivacaine and 4mg of dexamethasone
Bilateral Transverse Abdominis Plane BlockProcedure or surgery
Exparel-based solution mixed with 50mL of saline
| Study group | Role | What they receive |
|---|---|---|
| ITM group | Experimental | Patients will receive an intrathecal morphine block performed by the Anesthesiologist. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors 150 mcg of morphine will be administered intrathecally Receives: Procedure: Intrathecal Morphine Block |
| QL group | Active comparator | Patients will receive a bilateral quadratus lumborum block containing 30 mL of 0.25% bupivacaine and 4mg of dexamethasone. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors where the bilateral quadratus lumborum block will be performed by the Anesthesiologist Receives: Procedure: Bilateral Quadratus Lumborum Block |
| TAP block group | Active comparator | Patients will undergo a bilateral transverse abdominis plane block performed by the surgical team using an exparel-based solution mixed with 50mL of saline. This block will be performed intraoperatively before the incisions are closed Receives: Procedure: Bilateral Transverse Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of chemotherapy (in days) as deemed by a blinded medical oncologist
Measured: Day of surgery to first chemotherapy session, assessed on (Day 30, Day 60, Day 90 visits)
Secondary outcomes (6)
Time (in hours) to Return of Bowel Function, Defined as First Passage of Flatus or Stool
Measured: From end of surgery up to 14 days postoperatively
Incidence of ORADEs
Measured: From baseline up to 90 days post-surgery
Cumulative and postoperative morphine milligram equivalents
Measured: From baseline up to 90 days post-surgery
Hospital length of stay in days
Measured: Post-op to discharge, assessed up to 30 days postoperatively
Pain scores measured by Visual Analog Scale (VAS), 0-10
Measured: Postoperatively at 1, 2, and 6 hours after surgery (Day 0); at 24 and 48 hours (Days 1 and 2); and on Days 7, 30, 60, and 90
Patient satisfaction scores (Brief Pain Inventory - Short Form, Question 9 [BPI-sf9])
Measured: Post-op 14, 30, 60, and 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start3 Feb 2025
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Opioid Sparing TechniquesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153614
- Sponsor's protocol ID
- 5229
- Other IDs
- Institutional Review Board
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Opioid Sparing Techniques on Time to Initiation of Chemotherapy: A Randomized Single Blinded Control Study
- ClinicalTrials.gov ID
- NCT07153614
- Acronym / sponsor ID
- 5229
- Conditions
- Perioperative Opioid Sparing Techniques
- Keywords
- Opioid, Perioperative Opioid Sparing Techniques, Colorectal Cancer, Foregut Cancer, Hepatopancreatobiliary (HPB)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 4 Sep 2025 (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 primary purpose of this study is to determine if intrathecal morphine (ITM) administration is superior to quadratus lumborum block or surgeon administered transversus abdominis plane (TAP) blocks result in decreased time to initiation of chemotherapy following oncologic surgery.
The secondary objectives of this study are to determine:
- The difference between interventions in time to return of bowel function in days
- The difference between interventions in incidence of opioid related adverse drug events (ORADEs)
- The difference between interventions in cumulative and post-operative total morphine milligram equivalents
- The difference between interventions in quality-of-life assessment tool and patient satisfaction (brief pain index short form BPI-sf9)
- The difference between interventions in hospital length of stay in days
- The difference between cumulative pain scores between interventions
- The difference between short acting and long-acting bupivacaine in pain management and time to chemotherapy
The hypothesis is that preoperative intrathecal morphine administration will significantly reduce the time to initiation of postoperative chemotherapy.
Detailed description
Enhanced recovery after surgery (ERAS) has become the standard of perioperative care for patients undergoing oncologic surgery. Multimodal and regional anesthetic techniques to reduce postoperative pain and opioid requirements are a key component of ERAS. Epidural analgesia was considered standard in early ERAS protocols. however, it is labor-intensive, requires close postoperative follow-up, and may exacerbate hemodynamic instability.
Long-acting intrathecal (IT) opioid use in oncologic surgery has been described as an equianalgesic technique to epidural analgesia with an improved safety profile, although both have the potential for neurological complications and respiratory depression9. Quadratus lumborum (QL) block is an alternative opioid sparing technique to neuraxial analgesia for abdominal surgery. QL blocks can provide similar pain coverage as an epidural with decreased hemodynamic instability. However, it is limited by its relatively short duration of effect, which ranges from 6 to 12 h. Another method employed is the transversus abdominis plane block. One of the advantages of this technique is that it does not depend on a separate service to perform like ITM and QL as it is commonly performed by the surgeon during surgery. However, unlike the QL block which has been shown to spread to the lumbar plexus and even thoracic paravertebral space providing both somatic and visceral analgesia, TAP blocks only provide somatic analgesia coverage. TAP blocks are still frequently performed by oncologic surgeons though the long term success compared to QL and ITM blocks is unclear. Most research looking into the efficacy of these techniques has been aimed at studying their effects on pain scores, opioid requirements, and opioid related adverse drug events.
Time to initiation of adjuvant chemotherapy (AC) following oncologic surgery is an important predictor of survivability that has not yet been considered in QL vs. IT comparison studies. Two meta-analyses demonstrated that postponing the postoperative AC was associated with poor survival in colorectal cancer patients. Results from Biagi et al. showed that every 4 weeks delay result in a 14% decrease of overall survival (OS). Similarly, Guetz's study indicated that delaying the initiation of AC for > 8 weeks after operation significantly decreased OS. In pancreatic and colorectal cancer, several factors are involved in this metric. One of the more common factors in this patient population is gastrointestinal complications including ileus. Some of these complications can be affected by perioperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITM group | Experimental | Procedure: Intrathecal Morphine BlockPatients will receive an intrathecal morphine block performed by the Anesthesiologist. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors 150 mcg of morphine will be administered intrathecally |
| QL group | Active comparator | Procedure: Bilateral Quadratus Lumborum BlockPatients will receive a bilateral quadratus lumborum block containing 30 mL of 0.25% bupivacaine and 4mg of dexamethasone. This will be accomplished by placing the patient in a preoperative holding room with standard ASA monitors where the bilateral quadratus lumborum block will be performed by the Anesthesiologist |
| TAP block group | Active comparator | Procedure: Bilateral Transverse Abdominis Plane BlockPatients will undergo a bilateral transverse abdominis plane block performed by the surgical team using an exparel-based solution mixed with 50mL of saline. This block will be performed intraoperatively before the incisions are closed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-80 years of age
- Patients undergoing open surgery for foregut, HPB, and colorectal cancer
- Able to read and understand study procedures
- Willing to participate and sign an ICF
- If female of childbearing potential, subject must have a negative pregnancy test
Key exclusion criteria (18 listed)
- Chronic Opioid Use (received an opioid within 90 days preoperatively)
- Recreational Drug Use
- Patients with cognitive impairments that can affect their ability to give consent
- Patients that are currently taking anti-coagulants <7 days prior to surgery
- Pregnant or breastfeeding
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 |
|---|---|---|
| Intrathecal Morphine BlockMorphine 150 mcg | Procedure or surgery | ITM group |
| Bilateral Quadratus Lumborum Block30 mL of 0.25% bupivacaine and 4mg of dexamethasone | Procedure or surgery | QL group |
| Bilateral Transverse Abdominis Plane BlockExparel-based solution mixed with 50mL of saline | Procedure or surgery | TAP block group |
Primary outcome
Time to initiation of chemotherapy (in days) as deemed by a blinded medical oncologist
Time frame: Day of surgery to first chemotherapy session, assessed on (Day 30, Day 60, Day 90 visits)
6 secondary outcomes
Time (in hours) to Return of Bowel Function, Defined as First Passage of Flatus or Stool
Time frame: From end of surgery up to 14 days postoperatively
Incidence of ORADEs
Time frame: From baseline up to 90 days post-surgery
Cumulative and postoperative morphine milligram equivalents
Time frame: From baseline up to 90 days post-surgery
Hospital length of stay in days
Time frame: Post-op to discharge, assessed up to 30 days postoperatively
Pain scores measured by Visual Analog Scale (VAS), 0-10
Time frame: Postoperatively at 1, 2, and 6 hours after surgery (Day 0); at 24 and 48 hours (Days 1 and 2); and on Days 7, 30, 60, and 90
Patient satisfaction scores (Brief Pain Inventory - Short Form, Question 9 [BPI-sf9])
Time frame: Post-op 14, 30, 60, and 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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.
University of Tennessee Graduate School of Medicine
Knoxville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine Block, Bilateral Quadratus Lumborum Block and Bilateral Transverse Abdominis Plane Block in people with Perioperative Opioid Sparing Techniques, run by University of Tennessee Graduate School of Medicine 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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 4 Sep 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initiation of chemotherapy (in days) as deemed by a blinded medical oncologist (time frame: Day of surgery to first chemotherapy session, assessed on (Day 30, Day 60, Day 90 visits)). 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 4 Sep 2025.