A Phase 4 interventional study of Intrathecal Morphine and Epidural Analgesia in Postoperative Pain, Analgesia and Colorectal Cancer, sponsored by Meri Mirceta. Not yet recruiting at 1 site in Croatia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Meri Mirceta · Phase 4, Interventional, and Treatment
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 minimally invasive colorectal cancer surgery.
The investigators expect intrathecal morphine to provide better 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.
Participants of this study will be randomly selected adult patients with colorectal carcinoma undergoing laparoscopic 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 laparoscopic 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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 98 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Meri Mirceta is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
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.
Procedure: Epidural Analgesia
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.
Drug: Intrathecal Morphine
In this group, 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 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.
Pain intensity at rest 24 hours after surgery.
Level of pain intensity will be validated using Numeric Rating Scale ranging from 0-10.
Time frame: 24 hours
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
Time frame: 1, 3, 6, 24, 48, and 72 hours after surgery
Intraoperative use of fentanyl.
Total amount of administered fentanyl in mg.
Time frame: For the duration of surgery.
Time to the first request for rescue analgesia.
Measured in minutes.
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.
Measured in mg.
Time frame: Total amount of tramadol and metamizole within 72 hours after surgery.
Patient satisfaction
Measured with a 5-point Likert scale.
Time frame: 24, 48, and 72 hours after surgery
Quality of sleep.
Measured with a 5-point Likert scale.
Time frame: 24, 48, and 72 hours after surgery
Quality of Recovery
Measured with a 15-item Quality of Recovery 15 (QoR-15) scale.
Time frame: 72 hours after surgery
Length of stay (LOS) in HDU (high dependency unit)
Time to ward discharge in hours.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: After extubation and 24 hours after surgery.
Incidence of respiratory depression
Respiratory rate \<8 /min or need for assisted ventilation.
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.
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.
Time frame: Within 24 hours after surgery.
Incidence of post-dural puncture headache
Time frame: 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.
Time frame: Perioperative
Potoperative complications
Postoperative complications will be classified according to the Clavien Dindo Classification (1, 2, 3 a, 3 b, 4 a, 4 b, 5).
Time frame: 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.
Time frame: Within 30 days after surgery
Plan to share: No
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