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Comparing spinal morphine and epidural drug combination for pain relief in patients having open colorectal surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at pain control methods for people having open colorectal surgery, which is an operation on the colon or rectum that requires a vertical cut down the middle of the abdomen. The study will compare two different ways of managing pain after this type of surgery. One method uses a single injection of morphine given directly into the fluid around the spinal cord, which is called intrathecal use. The other method uses continuous pain relief through an epidural catheter placed in the mid-back area, which delivers a combination of medications including bupivacaine hydrochloride as a local painkiller, fentanyl citrate as a pain medication, and adrenaline as a substance that helps the other medications work better and longer. The purpose of the study is to find out whether the single spinal morphine injection works just as well as the continuous epidural pain relief in helping patients recover after surgery.

Patients in this study will be randomly assigned to receive either the spinal morphine injection or the epidural pain relief method. Both groups will also receive additional pain medications as needed to keep them comfortable. The study will measure how well patients are recovering using a questionnaire that asks about their overall well-being and recovery quality. This will be checked on the second day after surgery and at several other times up to one year after the operation. The study will also track pain levels, patient satisfaction with pain control, how quickly patients can move around and return to normal activities, how long they stay in the hospital, and whether they experience any unwanted effects from the treatments.

Throughout the study, various aspects of recovery will be monitored, including how much additional pain medication patients need, whether they experience side effects such as nausea, itching, drowsiness, or breathing problems, and how quickly their bowel function returns to normal. The study will also look at overall health-related quality of life, any confusion after surgery, and whether patients develop any complications. For patients who have cancer, the study will track when they are able to start chemotherapy treatment if needed. All of these measurements help researchers understand which pain control method allows for better recovery after colorectal surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment before surgery

    Before the surgery, your quality of recovery will be assessed using a questionnaire. This will serve as a baseline measurement to compare with your recovery after the surgery.

    Your health-related quality of life will be evaluated using a standard questionnaire.

    A baseline assessment for confusion will be performed.

  2. Step 2

    Pain relief method assignment

    You will be randomly assigned to receive one of two pain relief methods for your surgery.

    The first option is a single injection of morphine into the spinal fluid in your lower back. The medication used is morphine hydrochloride trihydrate 1 mg/ml, given as a one-time injection into the space around the spinal cord.

    The second option is continuous pain relief through a small tube placed in the space near your spine in the chest area. This method uses a combination of medications including bupivacaine hydrochloride (a numbing medication available in 0.5% injection form and 0.1% infusion form), fentanyl citrate 0.05 mg/ml (a pain medication), and adrenaline (a medication that helps prolong the effect). These medications are given continuously through the tube.

    Immediately after the pain relief procedure, you will be asked about any discomfort and pain you experienced during the placement of the injection or tube.

  3. Step 3

    Surgery

    Your colorectal surgery will be performed with an incision down the middle of your abdomen.

    During the surgery, the amount of fluids given through your vein, any medications used to maintain your blood pressure, and your urine output will be monitored and recorded.

    Your blood pressure will be monitored throughout the surgery.

    The time required to perform the pain relief procedure, the time from your arrival until anesthesia begins, and the time from the end of surgery until the breathing tube is removed will be recorded.

  4. Step 4

    Recovery period - Day of surgery and first week

    On the day of surgery and continuing until you leave the hospital (or at least for 7 days), your pain levels will be assessed both when you are resting and when you are moving. You will be asked to rate your pain on a scale from 0 to 11.

    Your satisfaction with pain management will be assessed daily using a scale ranging from very satisfied to very dissatisfied.

    If the primary pain relief method does not work well enough (pain rating of 4 or higher for more than 1 hour), alternative pain medications may be provided.

    The total amount of pain medications you receive will be recorded each day.

    Your oxygen levels and breathing rate will be monitored. If your oxygen level drops below normal or your breathing becomes too slow, appropriate treatment will be provided.

    Your level of alertness will be checked regularly.

    If you received the tube for continuous pain relief, the strength of your leg muscles will be assessed daily until the tube is removed or for at least 3 days.

    You will be monitored for side effects including nausea, vomiting, itching, and difficulty urinating.

    Your confusion level will be assessed daily.

    Your ability to move and get out of bed will be evaluated daily.

    The amount of fluids given through your vein and any medications used to maintain your blood pressure will be recorded.

    Your urine output will be measured on the first day after surgery.

    Your blood pressure will be monitored regularly.

    The return of your bowel function will be tracked, including when you first pass gas and have your first bowel movement, as well as when you first eat or drink.

    You will be asked daily about how well you slept the previous night.

  5. Step 5

    Recovery assessment - Days 1 through 7

    Your overall quality of recovery will be assessed daily using a questionnaire from day 1 through day 7 after surgery.

    Your health-related quality of life will be evaluated during this period.

    Any complications during your hospital stay will be monitored.

    The length of your hospital stay will be recorded.

  6. Step 6

    Follow-up assessment at 30 days

    At 30 days after surgery, your quality of recovery will be assessed using the same questionnaire.

    Your pain levels will be evaluated at rest and during activity.

    Your satisfaction with pain management will be assessed.

    You will be asked whether you are still taking pain medications for abdominal pain.

    The number of days you have been alive and at home since surgery will be recorded.

    Your health-related quality of life will be evaluated.

    Any complications will be classified and recorded.

    You will be asked about how well you have been sleeping.

    If your surgery was for cancer, the timing of any additional chemotherapy treatment will be noted.

  7. Step 7

    Follow-up assessment at one year

    At one year (365 days) after surgery, your quality of recovery will be assessed using the same questionnaire.

    Your pain levels will be evaluated at rest and during activity.

    Your satisfaction with pain management will be assessed.

    You will be asked whether you are still taking pain medications for abdominal pain.

    The number of days you have been alive and at home since surgery will be recorded.

    Your health-related quality of life will be evaluated.

    You will be asked about how well you have been sleeping.

    If your surgery was for cancer, information about any additional chemotherapy treatment will be recorded.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older
  • You must be scheduled for colorectal surgery, which is an operation on your large intestine or rectum where a portion is removed
  • The surgery must be performed through a midline incision, which is a cut made down the center of your abdomen
  • Your surgery must be planned in advance or scheduled as subacute, meaning it needs to be done within more than 24 hours after being notified but is not an emergency
  • You can be male or female

Who cannot join the trial?

10 criteria

  • Age restrictions: You cannot participate if you are under 18 years old or over 64 years old
  • Pregnancy or breastfeeding: You cannot participate if you are pregnant or nursing a baby
  • Allergy to medications: You cannot participate if you are allergic to morphine, which is a strong pain medication, or to local anesthetics, which are numbing medicines used during the procedure
  • Chronic pain conditions: You cannot participate if you have long-lasting pain that requires regular use of strong pain medications called opioids
  • Substance use disorders: You cannot participate if you have problems with alcohol or drug dependence
  • Communication difficulties: You cannot participate if you cannot understand or speak Swedish well enough to complete questionnaires about your recovery
  • Mental health conditions: You cannot participate if you have severe mental health problems that would make it difficult for you to understand the study or follow instructions
  • Spine problems: You cannot participate if you have conditions affecting your spine that would prevent the placement of a spinal injection or an epidural, which is a type of pain relief given through your back
  • Blood clotting issues: You cannot participate if you have problems with blood clotting or if you take blood thinning medications that cannot be safely stopped before surgery
  • Emergency surgery: You cannot participate if your surgery needs to be done urgently and cannot wait for the study procedures
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Investigated drugs

  • Intrathecal morphine

    is a pain medication that is injected directly into the fluid surrounding the spinal cord. This allows the medication to work directly on pain signals in the spine, providing pain relief after surgery. In this study, it is given as a single dose before or during the operation.

  • Thoracic epidural analgesia

    is a method of pain relief where pain medication is delivered continuously through a thin tube (catheter) placed in the space around the spinal cord in the chest area. This provides ongoing pain control during and after surgery by blocking pain signals from reaching the brain.

What is already known about the treatment

  • Intrathecal Morphine

    Intrathecal morphine is a pain medication delivered directly into the spinal fluid through a single injection into the space around the spinal cord. This method allows morphine, a strong pain reliever, to work directly on pain receptors in the spinal cord, blocking pain signals from reaching the brain while using a smaller dose than would be needed if given through a vein or muscle. It is commonly used in medical practice for managing severe pain after major surgeries, including operations on the abdomen and chest. In this clinical trial, researchers are testing whether a single dose of intrathecal morphine can provide pain relief that is just as good as continuous epidural analgesia for patients undergoing open colorectal surgery.

  • Thoracic Epidural Analgesia

    Thoracic epidural analgesia is a pain management technique where pain medication is continuously delivered through a thin tube (catheter) placed in the epidural space of the mid-back region near the chest area of the spine. This method works by numbing the nerves that carry pain signals from the surgical area to the brain, providing effective pain control for surgeries involving the chest and upper abdomen. It is a well-established standard treatment in medical practice for managing pain after major abdominal surgeries, including colorectal operations. In this clinical trial, it serves as the comparison treatment to determine if intrathecal morphine can provide similar quality of recovery for patients undergoing open colorectal surgery.

Investigated diseases

Colorectal diseases requiring surgical resection – This encompasses a range of conditions affecting the colon and rectum that necessitate surgical removal of the affected portion through an open midline incision. These diseases can include both benign and malignant conditions such as colorectal cancer, severe inflammatory bowel disease, complicated diverticular disease, and large polyps that cannot be removed endoscopically. The progression varies depending on the underlying condition, but generally these diseases have reached a stage where medical management alone is insufficient. In malignant cases, abnormal cells grow uncontrollably in the colorectal tissue and may spread to surrounding areas. In inflammatory conditions, chronic inflammation leads to tissue damage and complications that impair normal bowel function. Surgical intervention becomes necessary when the disease causes obstruction, bleeding, perforation, or fails to respond to conservative treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520262-58-01Protocol codeColoREDITEstimated enrolment124 patients

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