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Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery

ConditionsColorectal CarcinomaAnalgesia, PostoperativeLaparotomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMeri Mirceta

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine

    Drug

    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 Analgesia

    Procedure/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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Epidural groupActive comparator 1 intervention
Group B: Spinal groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Intraoperative use of fentanyl.

Total amount of administered fentanyl in mg.

Time frame
For the duration of surgery.
3

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)
4

Consumption of tramadol and metamizole.

Measured in mg.

Time frame
Total amount of tramadol and metamizole within 72 hours after surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meri Mirceta

Lead sponsor

University Hospital of Split

Sponsor institution

Source ClinicalTrials.gov
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