Opioid Sparing Techniques for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee Graduate School of Medicine

Must not be taking: Anticoagulants

Disqualifiers: Chronic opioid use, Recreational drug use, Cognitive impairments, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different pain relief methods for individuals undergoing surgery for colorectal cancer, aiming to determine which method enables patients to start chemotherapy sooner. It compares three approaches: administering morphine directly into the spine (Intrathecal Morphine Block) and two types of numbing injections near the abdomen, specifically the Bilateral Quadratus Lumborum Block and the Bilateral Transverse Abdominis Plane Block. The study also examines how each method affects recovery, including bowel function and hospital stay length. Candidates include those undergoing open surgery for colorectal cancer who can read and understand the study. The goal is to reduce opioid use and improve the overall treatment experience. As an unphased trial, this study provides a unique opportunity to contribute to understanding pain management options and potentially enhance recovery experiences for future patients.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking anticoagulants (blood thinners) at least 7 days before surgery. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown different safety levels for the three treatments being explored.

Research indicates that the quadratus lumborum block is generally safe when performed with ultrasound guidance, which helps avoid complications by accurately targeting the nerves. Studies suggest it effectively reduces the need for opioids during surgeries.

The transverse abdominis plane (TAP) block is also considered safe, with studies reporting no serious complications. It is often used for pain relief after abdominal surgeries and is part of enhanced recovery plans.

Intrathecal morphine has been used effectively for pain management after surgery, though it can cause side effects like nausea, vomiting, and trouble urinating. These side effects are usually manageable but occur more frequently with this treatment compared to the others.

Overall, while each treatment has its safety considerations, studies have provided a reasonable expectation of safety for those considering participation in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these opioid-sparing techniques for colorectal cancer because they offer alternatives to traditional pain management. Unlike standard care, which often relies heavily on opioids, these techniques aim to reduce opioid use and its associated side effects. The quadratus lumborum block and transverse abdominis plane block utilize local anesthetics to target pain at the source, potentially leading to more effective pain relief with fewer systemic effects. Meanwhile, the intrathecal morphine block delivers morphine directly into the spinal fluid, allowing for lower doses and minimizing systemic exposure. These approaches not only promise enhanced pain control but also a reduction in opioid-related complications, which is a significant advancement in postoperative care.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

This trial will compare different opioid-sparing techniques for managing pain after colorectal cancer surgery. Participants may receive an intrathecal morphine block, which research has shown can effectively manage pain and reduce the need for other painkillers, leading to fewer complications and faster recovery. Another group will receive a quadratus lumborum block, which studies indicate can lessen pain and the use of painkillers after surgery, aiding in recovery and maintaining stable blood flow. Additionally, some participants will undergo a transverse abdominis plane block, which has been proven to decrease pain after surgery and shorten hospital stays. Overall, these treatments aim to manage pain effectively and reduce side effects related to painkillers. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with colorectal cancer who are undergoing surgery and need pain management. They aim to see if certain pain control methods can help patients start chemotherapy sooner after surgery.

Inclusion Criteria

Able to read and understand study procedures

Willing to participate and sign an Informed Consent Form (ICF)

Patients scheduled for an AM admit procedure

Exclusion Criteria

Recreational Drug Use

Pregnant or breastfeeding

Chronic Opioid Use (received an opioid within 90 days preoperatively)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive either intrathecal morphine, quadratus lumborum block, or transversus abdominis plane block in a preoperative setting

1 day

1 visit (in-person)

Postoperative

Participants are monitored for return of bowel function, opioid-related adverse events, and pain management

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to initiation of chemotherapy

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral Quadratus Lumborum Block
• Bilateral Transverse Abdominis Plane Block
• Intrathecal Morphine Block

Trial Overview The study tests if intrathecal morphine is better than two other techniques, quadratus lumborum block or transversus abdominis plane blocks, at reducing the time before starting chemotherapy post-surgery.

How Is the Trial Designed?

Group I: ITM group Experimental Treatment 1 Intervention

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

Group II: QL group Active Control 1 Intervention

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

Group III: TAP block group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials

17

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12594477/

Quadratus Lumborum Block for Pain Management After ... Quadratus lumborum block (QLB) is an emerging regional anesthesia technique, and its efficacy in colorectal surgery (CRS) remains unclear.

2. rapm.bmj.com rapm.bmj.com/content/early/2025/10/28/rapm-2025-107136

Efficacy of anterior subcostal quadratus lumborum block for ... Anterior subcostal QLB may be integrated into enhanced recovery after surgery pathways for LCS as a safe and effective opioid-sparing option.

3. e-century.us e-century.us/files/ajtr/17/9/ajtr0167208.pdf

Effect of quadratus lumborum block combined with ... Conclusion: QLB combined with butorphanol-based PCIA effectively en- hances early postoperative analgesia and promotes hemodynamic and ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/20905068.2025.2464371

The effect of quadratus lumborum versus epidural block on ... The study aimed to compare the impact of TEA and subcostal anterior QLB on perioperative hemodynamic parameters of elderly patients undergoing colon cancer ...

5. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzM2NQ%3D%3D&journal=140

Quadratus Lumborum Block Spares Postoperative Opioid ... The current study was performed to assess the short- and long-term anal- gesic efficacy of QLB in patients under- going open gastrointestinal surgery. Our ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427021/

Ultrasound-guided quadratus lumborum block with general ... Ultrasound-guided QLB reduces the risk of blind punctures associated with traditional nerve block techniques by providing precise nerve localization, thereby ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdfdirect/10.1111/anae.16177

The effect of anterior quadratus lumborum block on We investigated the efficacy and safety of a bilateral anterior quadratus lumborum block in patients undergoing minimally invasive colorectal surgery. This was ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03230-8

Lateral quadratus lumborum block versus transversus ... The primary outcome was cumulative remifentanil administration during laparoscopic colorectal cancer surgeries. Secondary outcomes included ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03803267

Analgesia of Erector Spinae Plane Block Versus Quadratus ... Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both ...