Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic Colon Surgery

NCT06881563 | Not Yet Recruiting Phase 4

• 1 other identifier: 2181-147/01/06/LJ.Z.-23-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postoperative Pain; Analgesia; Colorectal Cancer; Surgery

Keywords

epidural; intrathecal morphine; laparoscopy; analgesia; colorectal cancer; postoperative pain

Outcome Measures

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.

  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

  1, 3, 6, 24, 48, and 72 hours after surgery

• Intraoperative use of fentanyl.

  For the duration of surgery.

• Time to the first request for rescue analgesia.

  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.

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

• Patient satisfaction

  24, 48, and 72 hours after surgery

Study Arms (2)

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.

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.

Drug: Intrathecal Morphine

Interventions

Intrathecal Morphine DRUG

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.

Spinal group

Epidural Analgesia PROCEDURE

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.

Epidural group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Meri Mirceta: lead

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Colorectal Neoplasms

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Svjetlana Došenović, MD, PhD

CONTACT

+38521556180; sdosenovic@yahoo.com

Meri Mirčeta, MD

CONTACT

+38521556180; mircetameri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The person performing the data analysis will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist, Doctor of Medicine (MD)

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)