Colorectal CarcinomaPhase 4NCT06935708
Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery
A Phase 4 study testing Intrathecal Morphine and Epidural Analgesia in people with Colorectal Carcinoma and Analgesia, Postoperative, run by Meri Mirceta at 1 site in Croatia.
Trial summary
Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma, Analgesia, Postoperative, Laparotomy
- What is being tested?
- Intrathecal Morphine and Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCroatia
- Study dates
- 8 Apr 2025to Nov 2026
- Phase
- Phase 4
- 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
- Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg/m2.
Who cannot join
- abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,
- thrombocytopenia, defined as a platelet count <80×10 9 L-1,
- pre-existing skin infection at the neuraxial anesthesia puncture site,
- pre-existing neurologic deficit, including peripheral neuropathy,
- patients with dementia or other medical condition that includes communication difficulties,
- patients with bradycardia (pulse <50/min) or with conduction block (2nd or 3rd degree)
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- history of opioid abuse,
- allergies to any of the drugs used in the study.
- Additionally, patients converted from laparoscopy to laparotomy due to technical surgical issues, patients with postoperative surgical complications (need for revision) or if epidural catheter placement/spinal anesthesia is unsuccessful even after an attempt by a senior anesthesiologist will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University hospital of Split
Split, 21000
About this study
Official title: Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial
Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery.
The investigators expect intrathecal morphine to provide equal pain relief at rest 24 hours after surgery, while epidural analgesia may be more effective during movement. By 48 to 72 hours, both methods should offer similar pain control. The epidural group may require fewer additional pain medications but could experience more side effects, including a higher risk of low blood pressure and technical difficulties. Additionally, these patients may have a slightly longer hospital stay. In contrast, the intrathecal morphine group may have fewer overall side effects. Despite these differences, patient satisfaction, sleep quality, and recovery are expected to be similar in both groups.
By evaluating these methods, this study aims to determine the most effective and safe approach to post-surgical pain management, improving comfort and recovery outcomes for patients.
Read the detailed description
Participants of this study will be randomly selected adult patients with colorectal carcinoma undergoing open colorectal resection who fulfill the inclusion criteria and sign the informed consent for participation.
This sample represents the population of adult patients with colorectal cancer undergoing open surgery by ERAS protocol in a tertiary hospital of a high-developed country.
Patients will be randomly divided into Epidural group (E group) or Spinal group (S group) and will receive different intraoperative and postoperative analgesia plans.
E group will be treated as a control group. Patients in S group will receive intrathecal morphine as analgesia for colorectal resection and it will be treated as experimental group.
Anesthesia induction and maintenance will be the same in both groups. The primary outcome is pain intensity at rest measured with the Numeric Rating Scale (0 = no pain and 10 = worst pain) 24 hours after surgery. Secondary outcome measures are analgesic consumption, time to rescue analgesia, patient satisfaction, quality of sleep, length of hospital stay, time to return of bowel function, and adverse events (such as respiratory depression, nausea or vomiting, hypotension and bradycardia).
Postoperative continuous epidural analgesia in the E group will consist of 2 μg/mL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL/h during the first 24 hours after surgery.
Additional epidural boluses will be allowed by the nursing staff for pain Numerical Rating Scale (NRS)≥4.
Both groups will receive standard multimodal analgesic protocol with the goal of postoperative pain NRS<4: intravenous (iv) paracetamol 1 g up to 4 times per day and iv metamizole 2.5 g up to 2 times per day and tramadol 50-100 mg iv as needed. In the control group, epidural analgesia will be used for postoperative pain relief for up to 24 h. An algorithm of postoperative rescue analgesia is established for each group.
Rescue antiemetics will be given in case of postoperative nausea and vomiting (PONV): metoclopramide 10 mg iv up to 3 times per day and granisetron 1 mg iv up to 3 times per day.
Severe pruritus will be treated with antihistamines or naloxone 40 mcg iv.
- Conditions
- Colorectal Carcinoma, Analgesia, Postoperative, Laparotomy
- Being tested
- Intrathecal Morphine, Epidural Analgesia
- Keywords
- postoperative pain, analgesia, epidural, intrathecal morphine, laparotomy
- Medical subject headings
- Colorectal Neoplasms, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
In Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally.
Epidural AnalgesiaProcedure or surgery
Epidural analgesia with levobupivacaine and fentanyl mixture. For intraoperative intermittent analgesia, Epidural group will be given a loading dose of 5-10 milliliters of a mixture of 10 micrograms per milliliter (μg/mL) of fentanyl (Fentanyl Piramal Critical Care, 50 mcg/ml) and 0.25% levobupivacaine (Levobupivakain Kabi 5 mg/ml), followed by intermittent 4-5 mL boluses as needed throughout the surgery. Postoperative continuous epidural analgesia in the epidural group will consist of 2 μg/mL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL/h during the first 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Epidural group | Active comparator | Epidural group will have an epidural catheter inserted in the T10/11 or T11/12 interspace using a midline approach. The epidural space will be identified by a loss of resistance to saline with a Tuohy 18G epidural needle. Subsequently, the epidural catheter will be inserted 4-6 cm into the epidural space and a test-dose of 2% lidocaine, 50 mg, to detect intrathecal misplacement will be given. Epidural group will subsequently receive intraoperative intermittent epidural analgesia followed by postoperative continuous infusion of a levobupivacaine and fentanyl mixture. Receives: Procedure: Epidural Analgesia |
| Spinal group | Experimental | In Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally. Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest 24 hours after surgery.
Level of pain intensity will be validated using Numeric Rating Scale ranging from 0-10.
Measured: 24 hours
Secondary outcomes (19)
Pain scores at rest and during movement at 1, 3, 6, 48, and 72 hours, and during movement at 24 h after surgery
Numeric Rating Scale
Measured: 1, 3, 6, 24, 48, and 72 hours after surgery
Intraoperative use of fentanyl.
Total amount of administered fentanyl in mg.
Measured: For the duration of surgery.
Time to the first request for rescue analgesia.
Measured in minutes.
Measured: From the time of the surgery until the time to the first request for rescue analgesia (up to 3 days after the surgery)
Consumption of tramadol and metamizole.
Measured in mg.
Measured: Total amount of tramadol and metamizole within 72 hours after surgery.
Patient satisfaction
Measured with a 5-point Likert scale.
Measured: 24, 48, and 72 hours after surgery
Quality of sleep.
Measured with a 5-point Likert scale.
Measured: 24, 48, and 72 hours after surgery
Quality of Recovery
Measured with a 15-item Quality of Recovery 15 (QoR-15) scale.
Measured: 72 hours after surgery
Length of stay (LOS) in HDU (high dependency unit)
Time to ward discharge in hours.
Measured: From the time of the admission to HDU until ward discharge (up to 30 days)
Length of hospital stay
Time from surgery to hospital discharge in days.
Measured: Form the day of surgery until hospital discharge (up to 90 days)
Time to ambulation
Measured in hours, defined as the patient independently getting out of bed.
Measured: From the end of surgery until patient ambulation (up to 30 days)
Time to gastro-intestinal recovery
First stool or flatus after surgery measured in hours, time to oral intake
Measured: From the end of surgery until the first documented stool, flatus or oral intake (up to 3 days)
Sedation score
Measured with a Ramsay sedation scale (1-6)
Measured: After extubation and 24 hours after surgery.
Incidence of respiratory depression
Respiratory rate <8 /min or need for assisted ventilation.
Measured: Within 24 hours after surgery.
Incidence of nausea or vomiting
Measured: Within 24 hours after surgery.
Incidence of shivering, pruritus, hypotension, bradycardia.
Hypotension defined as systolic blood pressure less than 90 mmHg or diastolic less than 50 mmHg, mean arterial pressure < 60 mmHg, or decline >20% from baseline, and bradycardia defined as heart rate <50/min.
Measured: Within 24 hours after surgery
Incidence of post-dural puncture headache
Measured: Within 72 hours after surgery.
Incidence of technique failure
Need to convert to a second analgesic technique due to multiple reasons, e.g., inability to perform spinal puncture, inability to insert an epidural catheter, inadequate analgesia, epidural catheter malfunction, or dislodgement.
Measured: Perioperative
Postoperative complications
Postoperative complications will be classified according to the Clavien Dindo Classification (1, 2, 3 a, 3 b, 4 a, 4 b, 5).
Measured: Until hospital discharge (up to 90 days)
Readmission rate
Readmission is defined as patient admission related to surgical procedure within 30 days after initial discharge.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start8 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meri Mirceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meri Mirceta, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935708
- Sponsor's protocol ID
- 2181-147/01/06/LJ.Z.-25-02
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06935708
- Acronym / sponsor ID
- 2181-147/01/06/LJ.Z.-25-02
- Conditions
- Colorectal Carcinoma, Analgesia, Postoperative, Laparotomy
- Keywords
- postoperative pain, analgesia, epidural, intrathecal morphine, laparotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Meri MircetaUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Apr 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.
Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery.
The investigators expect intrathecal morphine to provide equal pain relief at rest 24 hours after surgery, while epidural analgesia may be more effective during movement. By 48 to 72 hours, both methods should offer similar pain control. The epidural group may require fewer additional pain medications but could experience more side effects, including a higher risk of low blood pressure and technical difficulties. Additionally, these patients may have a slightly longer hospital stay. In contrast, the intrathecal morphine group may have fewer overall side effects. Despite these differences, patient satisfaction, sleep quality, and recovery are expected to be similar in both groups.
By evaluating these methods, this study aims to determine the most effective and safe approach to post-surgical pain management, improving comfort and recovery outcomes for patients.
Detailed description
Participants of this study will be randomly selected adult patients with colorectal carcinoma undergoing open colorectal resection who fulfill the inclusion criteria and sign the informed consent for participation.
This sample represents the population of adult patients with colorectal cancer undergoing open surgery by ERAS protocol in a tertiary hospital of a high-developed country.
Patients will be randomly divided into Epidural group (E group) or Spinal group (S group) and will receive different intraoperative and postoperative analgesia plans.
E group will be treated as a control group. Patients in S group will receive intrathecal morphine as analgesia for colorectal resection and it will be treated as experimental group.
Anesthesia induction and maintenance will be the same in both groups. The primary outcome is pain intensity at rest measured with the Numeric Rating Scale (0 = no pain and 10 = worst pain) 24 hours after surgery. Secondary outcome measures are analgesic consumption, time to rescue analgesia, patient satisfaction, quality of sleep, length of hospital stay, time to return of bowel function, and adverse events (such as respiratory depression, nausea or vomiting, hypotension and bradycardia).
Postoperative continuous epidural analgesia in the E group will consist of 2 μg/mL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL/h during the first 24 hours after surgery.
Additional epidural boluses will be allowed by the nursing staff for pain Numerical Rating Scale (NRS)≥4.
Both groups will receive standard multimodal analgesic protocol with the goal of postoperative pain NRS<4: intravenous (iv) paracetamol 1 g up to 4 times per day and iv metamizole 2.5 g up to 2 times per day and tramadol 50-100 mg iv as needed. In the control group, epidural analgesia will be used for postoperative pain relief for up to 24 h. An algorithm of postoperative rescue analgesia is established for each group.
Rescue antiemetics will be given in case of postoperative nausea and vomiting (PONV): metoclopramide 10 mg iv up to 3 times per day and granisetron 1 mg iv up to 3 times per day.
Severe pruritus will be treated with antihistamines or naloxone 40 mcg iv.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural group | Active comparator | Procedure: Epidural AnalgesiaEpidural group will have an epidural catheter inserted in the T10/11 or T11/12 interspace using a midline approach. The epidural space will be identified by a loss of resistance to saline with a Tuohy 18G epidural needle. Subsequently, the epidural catheter will be inserted 4-6 cm into the epidural space and a test-dose of 2% lidocaine, 50 mg, to detect intrathecal misplacement will be given. Epidural group will subsequently receive intraoperative intermittent epidural analgesia followed by postoperative continuous infusion of a levobupivacaine and fentanyl mixture. |
| Spinal group | Experimental | Drug: Intrathecal MorphineIn Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg/m2.
Key exclusion criteria (9 listed)
- abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,
- thrombocytopenia, defined as a platelet count <80×10 9 L-1,
- pre-existing skin infection at the neuraxial anesthesia puncture site,
- pre-existing neurologic deficit, including peripheral neuropathy,
- patients with dementia or other medical condition that includes communication difficulties,
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 MorphineIn Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally. | Drug | Spinal group |
| Epidural AnalgesiaEpidural analgesia with levobupivacaine and fentanyl mixture. For intraoperative intermittent analgesia, Epidural group will be given a loading dose of 5-10 milliliters of a mixture of 10 micrograms per milliliter (μg/mL) of fentanyl (Fentanyl Piramal Critical Care, 50 mcg/ml) and 0.25% levobupivacaine (Levobupivakain Kabi 5 mg/ml), followed by intermittent 4-5 mL boluses as needed throughout the surgery. Postoperative continuous epidural analgesia in the epidural group will consist of 2 μg/mL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL/h during the first 24 hours after surgery. | Procedure or surgery | Epidural group |
Primary outcome
Pain intensity at rest 24 hours after surgery.
Time frame: 24 hours
Level of pain intensity will be validated using Numeric Rating Scale ranging from 0-10.
19 secondary outcomes
Pain scores at rest and during movement at 1, 3, 6, 48, and 72 hours, and during movement at 24 h after surgery
Time frame: 1, 3, 6, 24, 48, and 72 hours after surgery
Intraoperative use of fentanyl.
Time frame: For the duration of surgery.
Time to the first request for rescue analgesia.
Time frame: From the time of the surgery until the time to the first request for rescue analgesia (up to 3 days after the surgery)
Consumption of tramadol and metamizole.
Time frame: Total amount of tramadol and metamizole within 72 hours after surgery.
Patient satisfaction
Time frame: 24, 48, and 72 hours after surgery
Quality of sleep.
Time frame: 24, 48, and 72 hours after surgery
Quality of Recovery
Time frame: 72 hours after surgery
Length of stay (LOS) in HDU (high dependency unit)
Time frame: From the time of the admission to HDU until ward discharge (up to 30 days)
Length of hospital stay
Time frame: Form the day of surgery until hospital discharge (up to 90 days)
Time to ambulation
Time frame: From the end of surgery until patient ambulation (up to 30 days)
Time to gastro-intestinal recovery
Time frame: From the end of surgery until the first documented stool, flatus or oral intake (up to 3 days)
Sedation score
Time frame: After extubation and 24 hours after surgery.
Incidence of respiratory depression
Time frame: Within 24 hours after surgery.
Incidence of nausea or vomiting
Time frame: Within 24 hours after surgery.
Incidence of shivering, pruritus, hypotension, bradycardia.
Time frame: Within 24 hours after surgery
Incidence of post-dural puncture headache
Time frame: Within 72 hours after surgery.
Incidence of technique failure
Time frame: Perioperative
Postoperative complications
Time frame: Until hospital discharge (up to 90 days)
Readmission rate
Time frame: Within 30 days after surgery
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 20 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal Morphine and Epidural Analgesia in people with Colorectal Carcinoma and Analgesia, Postoperative, run by Meri Mirceta at 1 site in Croatia.
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 9 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 20 Apr 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 Croatia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Svjetlana Došenović, MD, PhD (+38521556180, sdosenovic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest 24 hours after surgery. (time frame: 24 hours). 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 20 Apr 2025.