MORPHINE HYDROCHLORIDE TRIHYDRATE for Colorectal disease requiring resection

Inclusion criteria

• {"criterion_text":"-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

• {"criterion_text":"-Contraindications for neuraxial blockade (anticoagulant or antithrombotic therapy in doses according to European guidelines, coagulopathy, volume depletion, sepsis)"}
• {"criterion_text":"-Opioid usage (chronic pain or drug addiction)"}
• {"criterion_text":"-Cognitive dysfunction and/or inability to understand instructions"}
• {"criterion_text":"-Allergy to drugs used"}
• {"criterion_text":"-Pregnancy"}

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Quality of Recovery-15 (Swedish version) measured postoperative day 2, adjusted for preoperative score; MCID between treatment groups set to 8."}

Secondary endpoints

• {"endpoint_text":"-Mean Quality of Recovery-15 Swedish version postoperative day 1-7, 30 and 365 with adjustment for preoperative score","definition_or_measurement_approach":"QoR-15 (Swedish) measured postoperative days 1-7, day 30, and day 365 adjusted for preoperative score."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Pain intensity measured at rest and activity using 11-point NRS and verbal rating scale on POD0-discharge (or at least POD7), POD30, and POD365; MCID = 1.0."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Patient satisfaction assessed on Likert scale on POD1-discharge (or at least POD7), POD30, and POD365."}
• {"endpoint_text":"-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).","definition_or_measurement_approach":"Failure defined as persistent NRS ≥4 >1 hour despite adequate analgesia; events include postoperative placement of TEA catheter, administration of IT morphine or peripheral nerve block, need for esketamine/lidocaine/PCIVA morphine, premature stop of TEA. Measured POD0-discharge (or at least POD7)."}
• {"endpoint_text":"-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).","definition_or_measurement_approach":"Cumulative opioid consumption expressed as MME; MCID defined as 10 mg IV or 40% per 24 h; measured POD0-discharge (or at least POD7)."}
• {"endpoint_text":"-Long term opioid requirement, defined as still taking opioids for abdominal pain on POD30 and/or POD365.","definition_or_measurement_approach":"Assessment of ongoing opioid use for abdominal pain at POD30 and POD365."}
• {"endpoint_text":"-Length of stay. LoS measured in days, defined as time from operation to discharged from hospital. MCID is defined as 1 day.","definition_or_measurement_approach":"Hospital length of stay in days from operation to discharge; MCID = 1 day."}
• {"endpoint_text":"-Mortality. Registered at discharge, POD30, POD365","definition_or_measurement_approach":"All-cause mortality recorded at discharge, POD30, and POD365."}
• {"endpoint_text":"-Days alive and home registred at POD 30 and POD 365. MCID is defined as 3 days at POD30.","definition_or_measurement_approach":"Days alive and at home registered at POD30 and POD365; MCID = 3 days at POD30."}
• {"endpoint_text":"-Health related quality of life using EQ-5D-5L. Registered at baseline at preanaesthetic clinic, POD1-discharge (at least POD7), POD30, POD365","definition_or_measurement_approach":"EQ-5D-5L measured at baseline (pre-anaesthetic clinic), POD1-discharge (at least POD7), POD30, and POD365."}
• {"endpoint_text":"-Postoperative delirium using Nu-DESC score, score > 2 is considered delirium. Registered at baseline at preanaesthetic clinic, POD0-discharge (at least POD7)","definition_or_measurement_approach":"Nu-DESC score >2 defines delirium; assessed baseline (pre-anaesthetic clinic) and POD0-discharge (at least POD7)."}
• {"endpoint_text":"-Mobilisation using modified surgical intensive care unit optimal mobilisation score. Measured as time to mSOMS ≥ 2. Assessments at POD0-discharge (at least POD7).","definition_or_measurement_approach":"Time to achieve mSOMS ≥ 2 measured; assessments POD0-discharge (at least POD7)."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Subjective discomfort by VRS and maximum pain by NRS-11 assessed immediately after neuraxial procedure."}
• {"endpoint_text":"-Time to administer neuraxial block.","definition_or_measurement_approach":"Measured time required to administer neuraxial block (timing details not further specified)."}
• {"endpoint_text":"-Time from patient arrival to induction of anaesthesia.","definition_or_measurement_approach":"Time interval from patient arrival to induction of anaesthesia (timing details not further specified)."}
• {"endpoint_text":"-Time from operation finished to extubation.","definition_or_measurement_approach":"Interval from end of operation to extubation."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"IV fluid dose intraoperatively (ml per minute of operation) and postoperatively (ml per day); registered intraoperative and POD0-discharge."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Vasopressor dose intraoperatively (mg per minute of operation) and postoperatively (total mg); registered intraoperatively and on POD1."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Urine output intraoperatively (ml per operation hour) and postoperative day 1 (ml per PACHU stay hour)."}
• {"endpoint_text":"-Acute kidney injury during hospital stay using KDIGO definition. Routinely measured creatinine from preoperative to discharge will be recorded.","definition_or_measurement_approach":"AKI assessed using KDIGO definition based on routine creatinine measurements preoperative to discharge."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Respiratory depression endpoints defined by desaturation (PaO2<8 kPa or SpO2<90% requiring oxygen), bradypnoea (<10 breaths/min), need for IV naloxone, hypoventilation (pCO2>6.6 kPa), and need for mechanical ventilation; monitored per national guidelines; registered POD0-discharge."}
• {"endpoint_text":"-Sedation using richmond agitation-sedation scale. Oversedation is defined as Richmond Agitation-Sedation Scale < -2. Registered POD0-discharge.","definition_or_measurement_approach":"Sedation measured by RASS; oversedation defined as RASS < -2; registered POD0-discharge."}
• {"endpoint_text":"-Motor block using Bromage score. Registered POD0-discontinuation of TEA or at least POD3.","definition_or_measurement_approach":"Motor block assessed by Bromage score; registered POD0-discontinuation of TEA or at least POD3."}
• {"endpoint_text":"-Incidence of postdural puncture headache. Registered at POD0-discharge.","definition_or_measurement_approach":"Incidence of postdural puncture headache recorded POD0-discharge."}
• {"endpoint_text":"-Incidence of postoperative nausea and vomiting (PONV). Registered postoperative at 0-6h, 6-24h and overall during hospital stay.","definition_or_measurement_approach":"PONV incidence recorded at 0-6h, 6-24h, and overall during hospital stay."}
• {"endpoint_text":"-Incidence of pruritus. Registered postoperative at 0-6h, 6-24h and overall during hospital stay.","definition_or_measurement_approach":"Pruritus incidence recorded at 0-6h, 6-24h, and overall during hospital stay."}
• {"endpoint_text":"-Urinary catheter needed due to urinary retention. POD0-discharge (at least POD7).","definition_or_measurement_approach":"Requirement for urinary catheter due to retention recorded POD0-discharge (at least POD7)."}
• {"endpoint_text":"-Grading of complications according to Clavien-Dindo at POD30.","definition_or_measurement_approach":"Complications graded by Clavien-Dindo at POD30."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Time from end of surgery to return of bowel function (time to flatus, first stool) and time to first oral intake; registered POD1-discharge."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Sleep disturbance assessed by single-question with predefined options; recorded POD1-discharge (at least POD7), POD30, and POD365."}
• {"endpoint_text":"-Time to start of adjuvant chemotherapy in malignant cases. Cut-off at <8 weeks or >8 weeks. Registered at POD365.","definition_or_measurement_approach":"Time to start adjuvant chemotherapy in malignant cases categorized <8 weeks or >8 weeks; registered at POD365."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Hypotension defined intraoperatively as MAP <65 mmHg >5 min; postoperatively MAP <65 >5 min and/or need for fluid bolus/vasopressor to maintain MAP>65; registered preoperative, intraoperative, and POD0-discharge."}

Sweden

Earliest CTIS Part Ii Submission Date

19-01-2026

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

9

Number Of Sites

3

Number Of Participants

124

Primary sponsor

Full Name

Region Vaestmanland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden