Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06881563

Rekrutierung geplant

Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic Colon Surgery

Interventionsstudie

Phase 4

University Hospital Split

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente, Eingriff

Erforderliche Mutationen

Keine

Studie gestartet

2025-03-27

Zuletzt vom Sponsor aktualisiert

2025-03-25

Voraussichtlicher Abschluss

2026-07-01

Eignung

Einschlusskriterien

* 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.

Ausschlusskriterien

* 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.

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer98

Arme & Interventionen

Arme

Interventionen

Typ: Active Comparator

Beschreibung: 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.

Interventionen:

Intrathecal Morphine
Epidural Analgesia

Ergebnismessungen

Primäre Ergebnismessungen

Pain intensity at rest 24 hours after surgery.24 hours

Level of pain intensity will be validated using Numeric Rating Scale ranging from 0-10.

Sekundäre Ergebnismessungen

Pain scores at rest and during movement at 1, 3, 6, 48, and 72 hours, and during movement at 24 h after surgery1, 3, 6, 24, 48, and 72 hours after surgery

Numeric Rating Scale

Intraoperative use of fentanyl.For the duration of surgery.

Total amount of administered fentanyl in mg.

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)

Measured in minutes.

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

Measured in mg.

Patient satisfaction24, 48, and 72 hours after surgery

Measured with a 5-point Likert scale.

Quality of sleep.24, 48, and 72 hours after surgery

Measured with a 5-point Likert scale.

Quality of Recovery72 hours after surgery

Measured with a 15-item Quality of Recovery 15 (QoR-15) scale.

Length of stay (LOS) in HDU (high dependency unit)From the time of the admission to HDU until ward discharge (up to 30 days)

Time to ward discharge in hours.

Length of hospital stayForm the day of surgery until hospital discharge (up to 90 days)

Time from surgery to hospital discharge in days.

Time to ambulationFrom the end of surgery until patient ambulation (up to 30 days)

Measured in hours, defined as the patient independently getting out of bed.

Time to gastro-intestinal recoveryFrom the end of surgery until the first documented stool, flatus or oral intake (up to 3 days)

First stool or flatus after surgery measured in hours, time to oral intake

Sedation scoreAfter extubation and 24 hours after surgery.

Measured with a Ramsay sedation scale (1-6)

Incidence of respiratory depressionWithin 24 hours after surgery.

Respiratory rate <8 /min or need for assisted ventilation.

Incidence of nausea or vomitingWithin 24 hours after surgery.

Incidence of shivering, pruritus, hypotension, bradycardia.Within 24 hours after surgery.

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.

Incidence of post-dural puncture headacheWithin 72 hours after surgery.

Incidence of technique failurePerioperative

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.

Potoperative complicationsUntil hospital discharge (up to 90 days)

Postoperative complications will be classified according to the Clavien Dindo Classification (1, 2, 3 a, 3 b, 4 a, 4 b, 5).

Readmission rateWithin 30 days after surgery

Readmission is defined as patient admission related to surgical procedure within 30 days after initial discharge.

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Studienzentren

University Hospital Split
Split, HR

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