Comparison of spinal morphine and epidural analgesia for pain control in open colorectal surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Vaestmanland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-01-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Department of Anaesthesia and Intensive Care, Västmanland Hospital Västerås · Regional Research Council Mid Sweden · Region Västmanland – Uppsala University, Centre for Clinical Research, Västmanland Hospital Västerås

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

This trial aims to investigate whether intrathecal morphine is comparable (non-inferior) to thoracic epidural analgesia regarding patient quality of recovery measured with Quality of Recovery-15 swedish version after open colorectal surgery.

Secondary objectives 1

1. Secondary aims include investigation whether intrathecal morphine is comparable (non-inferior) to thoracic epidural analgesia regarding pain intensity, opioid usage, patient satisfation, length of stay, health related quality of life, postoperative delirium, mobilization, respiratory depression, sedation, motor block, postoperative nausea and vomiting, gastrointestinal function and sleep disturbance.

Conditions and MedDRA coding

All diseases requiring resective colorectal surgery with a midline incision.

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients aged 18 years or older undergoing resective colorectal surgery with a midline incision in the elective or subacute (priority of surgery within >24 hours after notification) setting.

Exclusion criteria 5

1. Contraindications for neuraxial blockade (anticoagulant or antithrombotic therapy in doses according to European guidelines, coagulopathy, volume depletion, sepsis)
2. Opioid usage (chronic pain or drug addiction)
3. Cognitive dysfunction and/or inability to understand instructions
4. Allergy to drugs used
5. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean Quality of Recovery-15 Swedish version for post operative day 2 with adjustment for preoperative score. The minimally clinically important difference (MCID) between treatment groups is set to 8.

Secondary endpoints 32

1. Mean Quality of Recovery-15 Swedish version postoperative day 1-7, 30 and 365 with adjustment for preoperative score
2. Pain intensity at rest and activity using 11 point numeric rating scale and verbal rating scale on postoperative day 0-discharge or atleast postoperative day 7, postoperative day 30 and 365. MCID 1,0.
3. Patient satisfaction with postoperative pain management using Likert scale ranging very satisfied, satisfied, neutral, dissatisfied, very dissatisfied on postoperative day 1-discharge or atleast postoperative day 7, postoperative day 30 and 365.
4. Failure of primary analgesic method defined as persistent insufficient analgesia with NRS ≥4 for more than 1 hour despite adequate use of epidural and/or additional systemic analgesia. Postoperative placement of TEA catheter, administration of intrathecal morphine or peripheral nerve blockade. Postoperative need for esketamine-infusion, lidocaine-infusion or PCIVA morphine. Premature stop of TEA. Measured on POD 0 - discharge (or at least POD7).
5. Cumulative dose of opioids using Morphine Milligram Equivalents and MCID 10 mg IV or 40% per 24 h. Measured on POD 0 - discharge (or at least POD7).
6. Long term opioid requirement, defined as still taking opioids for abdominal pain on POD30 and/or POD365.
7. Length of stay. LoS measured in days, defined as time from operation to discharged from hospital. MCID is defined as 1 day.
8. Mortality. Registered at discharge, POD30, POD365
9. Days alive and home registred at POD 30 and POD 365. MCID is defined as 3 days at POD30.
10. Health related quality of life using EQ-5D-5L. Registered at baseline at preanaesthetic clinic, POD1-discharge (at least POD7), POD30, POD365
11. Postoperative delirium using Nu-DESC score, score > 2 is considered delirium. Registered at baseline at preanaesthetic clinic, POD0-discharge (at least POD7)
12. Mobilisation using modified surgical intensive care unit optimal mobilisation score. Measured as time to mSOMS ≥ 2. Assessments at POD0-discharge (at least POD7).
13. Subjective discomfort and maximum pain during neuraxial procedure. Subjective discomfort using VRS 0, no discomfort; 1, minimal; 2, moderate; 3, severe and Maximum pain related to ITM and TEA administration using NRS-11. Assessed immediately after neuraxial procedure.
14. Time to administer neuraxial block.
15. Time from patient arrival to induction of anaesthesia.
16. Time from operation finished to extubation.
17. Intravenous fluid dose. Intraoperative: Total volume intravenous fluid dose in ml divided by duration of operation in minutes. Postoperative: Total volume intravenous fluid in ml per day. Registered intraoperative, POD0-discharge
18. Vasopressor dose. Intraoperative: Total dose for each vasopressor in mg divided by duration of operation in minutes. Postoperative: Total dose for each vasopressor in mg. Registered intraoperatively and on POD1.
19. Urine output during operation and on postoperative day 1. Intraoperative: Total volume in ml divided by duration of operation in hours Postoperative: Total volume in ml divided by duration of stay in PACHU in hours.
20. Acute kidney injury during hospital stay using KDIGO definition. Routinely measured creatinine from preoperative to discharge will be recorded.
21. Respiratory depression. Desaturation defined as PaO2<8 kPa on room air or SpO2 < 90% and requiring oxygen therapy or. Bradypnoea defined as respiratory frequency <10 breaths/minute. Need for iv naloxone treatment due to respiratory insufficiency. Hypoventilation defined as pCO2 >6,6 kPa. Need for mechanical ventilation. Monitored according to national guidelines. Registered POD 0 to discharge.
22. Sedation using richmond agitation-sedation scale. Oversedation is defined as Richmond Agitation-Sedation Scale < -2. Registered POD0-discharge.
23. Motor block using Bromage score. Registered POD0-discontinuation of TEA or at least POD3.
24. Incidence of postdural puncture headache. Registered at POD0-discharge.
25. Incidence of postoperative nausea and vomiting (PONV). Registered postoperative at 0-6h, 6-24h and overall during hospital stay.
26. Incidence of pruritus. Registered postoperative at 0-6h, 6-24h and overall during hospital stay.
27. Urinary catheter needed due to urinary retention. POD0-discharge (at least POD7).
28. Grading of complications according to Clavien-Dindo at POD30.
29. Time to gastrointestinal recovery. Measured as time from end of surgery to time to return of bowel function (time to flatus and time to passing first stool) and time to first oral intake. Registered at POD1-discharge.
30. Sleep disturbance. Assessment using the question “How did you sleep last night?” with predetermined options “excellent”, “neither well nor badly” and “badly" on POD1-discharge (atleast POD7), POD30 and POD365.
31. Time to start of adjuvant chemotherapy in malignant cases. Cut-off at <8 weeks or >8 weeks. Registered at POD365.
32. Hypotension. Non-invasive or invasive measurement. Intraoperative hypotension defined as MAP < 65 for more than 5 minutes. Postoperative hypotension defines as MAP < 65 for more than 5 minutes and/or need for fluid bolus and/or need for vasopressor to maintain MAP > 65 mmHg. Registered preoperative, intraoperative, POD0-discharge

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vaestmanland

Sponsor organisation

Region Vaestmanland

Address

Sigtunagatan

City

Vasteras

Postcode

721 89

Country

Sweden

Scientific contact point

Organisation

Region Vaestmanland

Contact name

Kent Nilsson

Public contact point

Organisation

Region Vaestmanland

Contact name

Kent Nilsson

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications