IV vs Epidural Opioids for Laparotomy Pain

Overseen By Melinda Seering, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Yair Rubin

Must not be taking: Opioids, Anticoagulants, Marijuana, others

Disqualifiers: Chronic pain, Substance abuse, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 4-5 days

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using opioids or have a history of chronic pain, you may not be eligible to participate.

What data supports the effectiveness of the treatment Epidural administered opioid for laparotomy pain?

Research shows that epidural analgesia can provide better pain control compared to intravenous opioids after major surgeries, such as mastectomy with reconstruction, which suggests it might also be effective for laparotomy pain. ^{1 2 3 4 5}

Is it safe to use IV or epidural opioids for pain relief after surgery?

Both IV and epidural opioids are used for pain relief after surgery, but they come with risks. IV opioids can cause sedation and breathing problems, while epidural opioids have fewer sedation issues but still require careful monitoring to prevent complications. ^{6 7 8 9 10}

How does epidural opioid treatment differ from intravenous opioid treatment for laparotomy pain?

Epidural opioids are administered directly into the space around the spinal cord, which can provide more targeted pain relief with potentially lower doses compared to intravenous opioids, which are delivered through the bloodstream. Studies have shown that patients receiving epidural opioids often require less medication and may experience fewer side effects than those receiving intravenous opioids. ^{2 5 6 11 12}

Research Team

Melinda Seering, MD

Principal Investigator

Univeristy of Iowa

Eligibility Criteria

This trial is for individuals undergoing laparotomy surgery who need pain control after the operation. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed inclusion and exclusion factors.

Inclusion Criteria

Patient is able to use a patient controlled pump

I can speak and understand English.

I am scheduled for an abdominal surgery that includes a cut above my belly button and will have an epidural.

Exclusion Criteria

I have a liver condition that affects how drugs are processed.

I have used opioids before surgery.

Routine use of marijuana

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous PCA or epidural PCEA opioids combined with local anesthetic for post-operative pain management

4-5 days

Daily visits for pain and satisfaction assessment

Follow-up

Participants are monitored for safety, effectiveness, and recovery post-treatment, including bowel function and discharge readiness

10 days

Daily assessments until discharge or maximum 10 days post-operatively

Treatment Details

Interventions

• Epidural administered opioid
• Intravenous administered opioid

Trial Overview The study is testing two common methods of delivering extra opioids for post-surgery pain relief: mixing them in an epidural solution or giving them separately through an IV. The goal is to see which method controls pain better.

Participant Groups

Group I: Control Active Control 1 Intervention

Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion

Group II: Treatment Active Control 1 Intervention

Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary

Who Is Running the Clinical Trial?

Yair Rubin

Lead Sponsor

Trials

1

Recruited

80+

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Findings from Research

In a study of 87 patients undergoing minimally invasive colorectal surgery, thoracic epidural analgesia (EA) did not show any clinical advantage over conventional intravenous analgesia (IA) in terms of pain relief or quality of life after surgery.

However, patients receiving EA experienced a higher incidence of hypotensive episodes and tended to use more narcotics, suggesting potential complications and increased medication use without improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Epidural Compared with Conventional Analgesia after Minimally Invasive Colorectal Surgery. Hanna, MH., Jafari, MD., Jafari, F., et al.[2017]

Epidural analgesia provided better pain relief in the acute postoperative phase compared to intravenous analgesia, with lower Visual Analog Scale (VAS) scores at 24 hours (3.29 vs 3.93).

Both epidural and intravenous analgesia showed similar effectiveness in managing chronic postoperative pain at 6 months, with no significant difference in VAS scores (2.03 for epidural vs 2.53 for intravenous).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of epidural and intravenous route for acute and chronic postoperative pain control in patients with gynecological malignancy. Balkan, B., Demirayak, G., Çetingök, H., et al.[2021]

In a study involving 20 patients undergoing major surgery, epidural fentanyl administration resulted in a lower incidence of significant heart rate reduction compared to intravenous administration, suggesting a potential safety benefit.

However, overall hemodynamic stability, plasma fentanyl levels, and other physiological markers showed no significant differences between the two methods, indicating that epidural fentanyl does not provide a clear clinical advantage over intravenous administration for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural and intravenous fentanyl produce equivalent effects during major surgery. Guinard, JP., Carpenter, RL., Chassot, PG.[2019]

Epidural analgesia provided significantly better pain relief compared to intravenous morphine patient-controlled analgesia (PCA) in patients undergoing major surgery, with lower pain scores recorded up to four days post-operation.

Patients receiving epidural analgesia had a shorter hospital stay, averaging 101 hours compared to 126 hours for those on PCA, indicating a potential benefit in recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia compared with intravenous morphine patient-controlled analgesia: postoperative outcome measures after mastectomy with immediate TRAM flap breast reconstruction. Correll, DJ., Viscusi, ER., Grunwald, Z., et al.[2019]

In a study of 30 elderly patients undergoing laparoscopic cholecystectomy, intravenous (IV) anesthesia techniques provided better hemodynamic stability, with significantly lower rates of intraoperative hypotension and bradycardia compared to epidural (EPI) techniques.

Patients receiving IV anesthesia reported higher satisfaction levels than those with EPI, primarily due to discomfort and anxiety associated with the epidural procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of intravenous-based and epidural-based techniques for anesthesia and postoperative analgesia in elderly patients undergoing laparoscopic cholecystectomy. Nishikawa, K., Kimura, S., Shimodate, Y., et al.[2018]

A novel multimodal analgesic approach using continuous bilateral rectus sheath catheters, along with gabapentin, clonidine, and nonsteroidal anti-inflammatories, effectively managed postoperative pain without the need for opioids or epidural analgesia in a patient after laparotomy.

The patient experienced minimal discomfort, was able to ambulate early, quickly advanced her diet, and had a short hospital stay, indicating high satisfaction and effective pain management with this alternative method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rectus sheath catheters for continuous analgesia after laparotomy--without postoperative opioid use. Malchow, R., Jaeger, L., Lam, H.[2012]

Epidural opioids provide effective postoperative pain relief in veterinary patients, offering prolonged analgesia with less sedation compared to traditional injectable opioids.

The technique is considered safe, with minimal associated risks, making it a favorable option for managing pain in veterinary surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative epidural analgesia. McMurphy, RM.[2019]

Intravenous lignocaine-fentanyl and epidural ropivacaine-fentanyl provide similar levels of pain relief after major abdominal oncosurgery, as indicated by comparable rescue fentanyl consumption and pain scores in a study of 60 patients.

However, the epidural group experienced a significantly higher rate of intraoperative hypotension, suggesting that intravenous lignocaine-fentanyl may be a safer option with fewer hemodynamic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Lignocaine-Fentanyl Versus Epidural Ropivacaine-Fentanyl for Postoperative Analgesia After Major Abdominal Oncosurgery: A Pilot Prospective Randomised Study. Nandi, R., Mishra, S., Garg, R., et al.[2022]

Opioid analgesics, while effective for treating acute pain in hospitalized patients, carry significant risks such as sedation, respiratory depression, and even death, highlighting the need for careful monitoring.

Nurses play a crucial role in patient safety by assessing risk factors for opioid-related adverse effects and utilizing evidence-based recommendations and technology for effective monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Hospitalized Adult Patients for Opioid-Induced Sedation and Respiratory Depression. Jungquist, CR., Smith, K., Nicely, KL., et al.[2018]

Epidural analgesia significantly reduces the risk of postoperative mortality and various complications, such as atrial fibrillation and respiratory depression, in adults undergoing surgery with general anesthesia, based on a review of 125 trials involving 9044 patients.

While epidural analgesia offers substantial benefits, it also carries risks, including increased chances of arterial hypotension and urinary retention, highlighting the need for careful risk-benefit assessments for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of epidural analgesia on mortality and morbidity after surgery: systematic review and meta-analysis of randomized controlled trials. Pöpping, DM., Elia, N., Van Aken, HK., et al.[2022]

In a clinical trial involving 20 patients undergoing upper abdominal surgery, those receiving fentanyl via the epidural route required significantly less medication compared to those receiving it intravenously, consuming more than twice as much fentanyl.

Both groups reported similar levels of pain, sedation, and nausea in the first 24 hours post-surgery, indicating that the method of administration did not adversely affect overall comfort or side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled on-demand epidural fentanyl. A comparison of patient-controlled on-demand fentanyl delivered epidurally or intravenously. Welchew, EA., Breen, DP.[2019]

In a study of 40 patients undergoing major abdominal surgery, epidural sufentanil combined with bupivacaine resulted in a 50% reduction in sufentanil consumption compared to intravenous administration, indicating enhanced analgesic efficacy.

The findings suggest that epidural sufentanil works through spinal mechanisms, providing effective pain relief without increasing side effects or altering pain scores compared to the IV route.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal mechanisms contribute to analgesia produced by epidural sufentanil combined with bupivacaine for postoperative analgesia. Joris, JL., Jacob, EA., Sessler, DI., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Epidural Compared with Conventional Analgesia after Minimally Invasive Colorectal Surgery. [2017]

2. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of epidural and intravenous route for acute and chronic postoperative pain control in patients with gynecological malignancy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Epidural and intravenous fentanyl produce equivalent effects during major surgery. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Epidural analgesia compared with intravenous morphine patient-controlled analgesia: postoperative outcome measures after mastectomy with immediate TRAM flap breast reconstruction. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

A comparison of intravenous-based and epidural-based techniques for anesthesia and postoperative analgesia in elderly patients undergoing laparoscopic cholecystectomy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Rectus sheath catheters for continuous analgesia after laparotomy--without postoperative opioid use. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative epidural analgesia. [2019]

8. Turkey pubmed.ncbi.nlm.nih.gov

Intravenous Lignocaine-Fentanyl Versus Epidural Ropivacaine-Fentanyl for Postoperative Analgesia After Major Abdominal Oncosurgery: A Pilot Prospective Randomised Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Monitoring Hospitalized Adult Patients for Opioid-Induced Sedation and Respiratory Depression. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of epidural analgesia on mortality and morbidity after surgery: systematic review and meta-analysis of randomized controlled trials. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Patient-controlled on-demand epidural fentanyl. A comparison of patient-controlled on-demand fentanyl delivered epidurally or intravenously. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Spinal mechanisms contribute to analgesia produced by epidural sufentanil combined with bupivacaine for postoperative analgesia. [2021]