PainPhase 1NCT06595329
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
A Phase 1 study testing Epidural analgesia and Intrathecal opioid analgesia in people with Pain and Renal Cancer, run by University Hospital of Split at 1 site in Croatia.
Trial summary
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Renal Cancer, Surgical Procedure, Unspecified
- What is being tested?
- Epidural analgesia and Intrathecal opioid analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jan 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over the age of 18, scheduled for an open radical or partial nephrectomy due to RCC.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
Who cannot join
- Patients who refuse to participate in this study.
- Patients with BMI > 35 kg/m2 or < 15 kg/m2.
- Patients with renal dysfunction (eGFR <15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).
- Patients with ASA physical status classification ≥ IV.
- Patients with contraindication for the interventions planned for in this study (allergies to anesthetic drugs used in this study, coagulation disorders, and infection at the injection site).
- Patients with chronic opioid dependence.
- Patients unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
- Patients for whom it is impossible to carry out the aforementioned interventions for technical reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lenko Šarić, Asst. Prof. contact
Croatia1 site, 1 recruiting
- Recruiting
Univeristy Hospital of Split
Split, 21000
Petra Bajto, MD, +385955234851
About this study
Official title: Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Open nephrectomy causes significant acute postoperative pain, and it can also lead to the development of chronic postoperative pain. Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery (ERAS) program.
In this prospective randomized clinical study, we plan to compare two different approaches to pain management regarding the level of acute pain (first 72 hours), side effects, systemic analgesics consumption, and hospital stay.
Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy. We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay.
Read the detailed description
This is a prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology.
Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.
Data sources:
Patient records (electronic and paper), direct measurements of patients' physiologic functions (perioperatively, during first 72 hours postoperatively), pain assessment at rest, and movement (Numerical rating scale (NRS)).
Ways of collection of data:
Direct measurements will be used for physiologic functions (change in heart rate and blood pressure). NRS questionnaire will be used to measure pain at rest and during movement in the first 72 hours. Patient records will be used for demographic data and to measure side effects of the received treatment and length of ICU and hospital stay.
Measurements will be conducted by anesthesiologists in the operating room, staff in the ICU during the period we are investigating (72 hours after the procedure) and researchers going through patients' records.
The population represented by the sample:
Patients scheduled for open radical or partial nephrectomy due to RCC.
Independent variables:
Demographic data (age, gender, weight), comorbidities, chronic medication, chronic pain medication, American Society of Anesthesiologists (ASA) score, duration of surgery, duration of anesthesia, baseline NRS score.
Intervention group:
Patients with RCC undergoing open nephrectomy randomized into a group receiving intrathecal morphine.
Control group:
Patients who will receive epidural analgesia will be treated as a control group given that epidural analgesia is the most favorable analgesic technique in accordance with ERAS protocol for major abdominal surgeries.
Tehnique of randomisation:
Participants will be randomly divided into two groups in a 1:1 ratio. Randomization will be performed using a computer program. A research coordinator will be designated to distribute and preserve randomization results.
Patients with RCC undergoing open nephrectomy will be asked to sign written informed consent before the enrolment should they choose to participate in this study. They will be instructed on how to self-assess pain severity via the numeric rating scale before surgery (NRS, an 11-point scale where 0 = no pain and 10 = most severe pain).
Treatment/intervention:
Patients undergoing open radical or partial nephrectomy will randomly receive either epidural analgesia or intrathecal morphine.
Patients in the Intervention group will receive a single dose of 300 mcg of morphine intrathecally before induction to general anesthesia. For patients in the control group, an epidural catheter will be placed before induction to the anesthesia. A local anesthetic (levobupivacaine 0.25%) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia.
Changes in heart rate, blood pressure, and the total dose of opioids administered are going to be measured intraoperatively. After the procedure, patients are going to be admitted to the intensive care unit in the Urology department. In the first 72 hours we will be measuring pain at rest using the Numerical rating scale (NRS), pain during cough using NRS, time of the first rescue analgesia, total dose of additional analgesics during 72 hours postoperatively, and the incidence of adverse effects (hypotension, bradycardia, nausea, vomiting, pruritus, respiratory insufficiency). We will analyze the quality of recovery and time to gastrointestinal function recovery. Complications of intervention will also be noted: accidental dural puncture, post-dural puncture headache, failed block, unintentional intravascular injection of local anesthetic, and local anesthetic toxicity. Length of ICU and hospital stay will also be measured. Patients will be exposed to intervention before the surgery, epidural catheter will be extracted after 24 hours. The expected duration of the study is one/two year/s.
- Conditions
- Pain, Renal Cancer, Surgical Procedure, Unspecified
- Being tested
- Epidural analgesia, Intrathecal opioid analgesia
- Keywords
- Pain management, open nephrectomy, renal cell carcinoma
- Medical subject headings
- Pain, Kidney Neoplasms, Agnosia, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaProcedure or surgery
After establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned puncture. The epidural space will be identified at the level of the tenth thoracic intervertebral space using the loss of resistance technique and an 18G Tuohy epidural needle. After placing the epidural catheter, 4 ml of local anesthetic Levobupivacaine 0.25% will be administered into the epidural space. After inducing general anesthesia, an additional 4 ml of Levobupivacaine 0.25% will be administered before the surgical incision. Subjects in the control group will receive an infusion of 0.125% Levobupivacaine for 24 hours after the procedure.
Intrathecal opioid analgesiaProcedure or surgery
Also called Intrathecal morphine analgesia
After establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned intrathecal puncture. Subsequently, at the selected site, the dura will be punctured using a spinal needle (25G Quincke spinal needle), and 0.3 mg of morphine will be administered to the patient. Following the intervention, the patient will be induced into general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Active comparator | An epidural catheter will be placed before induction to the anesthesia. A local anesthetic Levobupivacaine 0.25% (Levobupivakain Kabi ®, Fresenius Kabi Norge AS, Svinesundsveien, Norway, 5 mg/ml) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia. Receives: Procedure: Epidural analgesia |
| Intrathecal opioid analgesia | Other | Patients in the Intervention group will receive a single dose of 300 mcg of morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) intrathecally before induction to general anesthesia. Receives: Procedure: Intrathecal opioid analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score at 24 hours postoperatively
The primary outcome is the difference in NRS score at 24 hours postoperatively at rest and movement.
Numeric rating scale (NRS) will be used, ranging from 0-10, where 0 means no pain and 10 means most severe pain.
Measured: 24 hours
Secondary outcomes (9)
Intraoperative opioid consumption
Intraoperative opioid consumption in milligrams.
Measured: Intraoperatively.
Numeric rating scale (NRS) score at 1, 3, 6, 48 and 72 hours postoperatively
Numeric rating scale (an 11-point scale where 0 = no pain and 10 = most severe pain) score at rest and movement at 1, 3, 6, 48, and 72 hours postoperatively.
Measured: 72 hours.
Time to first rescue analgesia postoperatively
Time to first rescue analgesia postoperatively in hours.
Measured: In the first 72 hours postoperatively.
Total amount of rescue analgesia during 24 and 72 hours postoperatively
Total amount of rescue analgesia during 24 and 72 hours postoperatively in mg.
Measured: 72 hours.
Incidence of adverse effects
Incidence of adverse effects (hypotension defined as MAP ili SBP < 60 ili 90 mmHg for longer than 30 min), nausea, vomiting, accidental dural puncture with the needle or the catheter, post-dural puncture headache (headache occurring within 5 days after a lumbar puncture, accompanied by neck stiffness and subjective changes in hearing), failed block (total absence of any neuraxial block or the development of a partial block that is of insufficient height, duration, or quality), unintentional intravascular injection of local anesthetic, local anesthetic toxicity and respiratory depression (respiratory rate ≤8 breaths/min).
Measured: 72 hours.
Duration of procedure performance
Duration of procedure performance from the administration of local anesthetic for skin puncture to the removal of epidural or spinal needle in minutes.
Measured: During procedure execution (epidural catether placement, intrathecal administration of the drug).
Gastrointestinal function recovery
Gastrointestinal function recovery time (time to first bowel movement) in hours.
Measured: Up to 72 hours post operatively.
Hospital length of stay
Hospital length of stay in days.
Measured: Through study completion, an average of 1 year.
ICU length of stay
ICU length of stay in days.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jan 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology. Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenko Saric, University Hospital of Split
- Investigators
- Svjetlana Došenović, MD Phd, Principal investigator, UH Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595329
- Sponsor's protocol ID
- 2181-147/01/06/LJ.Z.-23-04
- Status last verified
- Mar 2025
- First submitted
- 27 Aug 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06595329
- Acronym / sponsor ID
- 2181-147/01/06/LJ.Z.-23-04
- Conditions
- Pain, Renal Cancer, Surgical Procedure, Unspecified
- Keywords
- Pain management, open nephrectomy, renal cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Open nephrectomy causes significant acute postoperative pain, and it can also lead to the development of chronic postoperative pain. Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery (ERAS) program.
In this prospective randomized clinical study, we plan to compare two different approaches to pain management regarding the level of acute pain (first 72 hours), side effects, systemic analgesics consumption, and hospital stay.
Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy. We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay.
Detailed description
This is a prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology.
Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.
Data sources:
Patient records (electronic and paper), direct measurements of patients' physiologic functions (perioperatively, during first 72 hours postoperatively), pain assessment at rest, and movement (Numerical rating scale (NRS)).
Ways of collection of data:
Direct measurements will be used for physiologic functions (change in heart rate and blood pressure). NRS questionnaire will be used to measure pain at rest and during movement in the first 72 hours. Patient records will be used for demographic data and to measure side effects of the received treatment and length of ICU and hospital stay.
Measurements will be conducted by anesthesiologists in the operating room, staff in the ICU during the period we are investigating (72 hours after the procedure) and researchers going through patients' records.
The population represented by the sample:
Patients scheduled for open radical or partial nephrectomy due to RCC.
Independent variables:
Demographic data (age, gender, weight), comorbidities, chronic medication, chronic pain medication, American Society of Anesthesiologists (ASA) score, duration of surgery, duration of anesthesia, baseline NRS score.
Intervention group:
Patients with RCC undergoing open nephrectomy randomized into a group receiving intrathecal morphine.
Control group:
Patients who will receive epidural analgesia will be treated as a control group given that epidural analgesia is the most favorable analgesic technique in accordance with ERAS protocol for major abdominal surgeries.
Tehnique of randomisation:
Participants will be randomly divided into two groups in a 1:1 ratio. Randomization will be performed using a computer program. A research coordinator will be designated to distribute and preserve randomization results.
Patients with RCC undergoing open nephrectomy will be asked to sign written informed consent before the enrolment should they choose to participate in this study. They will be instructed on how to self-assess pain severity via the numeric rating scale before surgery (NRS, an 11-point scale where 0 = no pain and 10 = most severe pain).
Treatment/intervention:
Patients undergoing open radical or partial nephrectomy will randomly receive either epidural analgesia or intrathecal morphine.
Patients in the Intervention group will receive a single dose of 300 mcg of morphine intrathecally before induction to general anesthesia. For patients in the control group, an epidural catheter will be placed before induction to the anesthesia. A local anesthetic (levobupivacaine 0.25%) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia.
Changes in heart rate, blood pressure, and the total dose of opioids administered are going to be measured intraoperatively. After the procedure, patients are going to be admitted to the intensive care unit in the Urology department. In the first 72 hours we will be measuring pain at rest using the Numerical rating scale (NRS), pain during cough using NRS, time of the first rescue analgesia, total dose of additional analgesics during 72 hours postoperatively, and the incidence of adverse effects (hypotension, bradycardia, nausea, vomiting, pruritus, respiratory insufficiency). We will analyze the quality of recovery and time to gastrointestinal function recovery. Complications of intervention will also be noted: accidental dural puncture, post-dural puncture headache, failed block, unintentional intravascular injection of local anesthetic, and local anesthetic toxicity. Length of ICU and hospital stay will also be measured. Patients will be exposed to intervention before the surgery, epidural catheter will be extracted after 24 hours. The expected duration of the study is one/two year/s.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology. Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Active comparator | Procedure: Epidural analgesiaAn epidural catheter will be placed before induction to the anesthesia. A local anesthetic Levobupivacaine 0.25% (Levobupivakain Kabi ®, Fresenius Kabi Norge AS, Svinesundsveien, Norway, 5 mg/ml) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia. |
| Intrathecal opioid analgesia | Other | Procedure: Intrathecal opioid analgesiaPatients in the Intervention group will receive a single dose of 300 mcg of morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) intrathecally before induction to general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over the age of 18, scheduled for an open radical or partial nephrectomy due to RCC.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
Key exclusion criteria (8 listed)
- Patients who refuse to participate in this study.
- Patients with BMI > 35 kg/m2 or < 15 kg/m2.
- Patients with renal dysfunction (eGFR <15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).
- Patients with ASA physical status classification ≥ IV.
- Patients with contraindication for the interventions planned for in this study (allergies to anesthetic drugs used in this study, coagulation disorders, and infection at the injection site).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesiaAfter establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned puncture. The epidural space will be identified at the level of the tenth thoracic intervertebral space using the loss of resistance technique and an 18G Tuohy epidural needle. After placing the epidural catheter, 4 ml of local anesthetic Levobupivacaine 0.25% will be administered into the epidural space. After inducing general anesthesia, an additional 4 ml of Levobupivacaine 0.25% will be administered before the surgical incision. Subjects in the control group will receive an infusion of 0.125% Levobupivacaine for 24 hours after the procedure. | Procedure or surgery | Epidural analgesia |
| Intrathecal opioid analgesiaAlso: Intrathecal morphine analgesiaAfter establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned intrathecal puncture. Subsequently, at the selected site, the dura will be punctured using a spinal needle (25G Quincke spinal needle), and 0.3 mg of morphine will be administered to the patient. Following the intervention, the patient will be induced into general anesthesia. | Procedure or surgery | Intrathecal opioid analgesia |
Primary outcome
NRS score at 24 hours postoperatively
Time frame: 24 hours
The primary outcome is the difference in NRS score at 24 hours postoperatively at rest and movement. Numeric rating scale (NRS) will be used, ranging from 0-10, where 0 means no pain and 10 means most severe pain.
9 secondary outcomes
Intraoperative opioid consumption
Time frame: Intraoperatively.
Numeric rating scale (NRS) score at 1, 3, 6, 48 and 72 hours postoperatively
Time frame: 72 hours.
Time to first rescue analgesia postoperatively
Time frame: In the first 72 hours postoperatively.
Total amount of rescue analgesia during 24 and 72 hours postoperatively
Time frame: 72 hours.
Incidence of adverse effects
Time frame: 72 hours.
Duration of procedure performance
Time frame: During procedure execution (epidural catether placement, intrathecal administration of the drug).
Gastrointestinal function recovery
Time frame: Up to 72 hours post operatively.
Hospital length of stay
Time frame: Through study completion, an average of 1 year.
ICU length of stay
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lenko Šarić, Asst. Prof. contact
Svjetlana Došenović, MD Phd principal investigator
UH Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epidural analgesia and Intrathecal opioid analgesia in people with Pain and Renal Cancer, run by University Hospital of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Bajto, MD (+385955234851, p.bajto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score at 24 hours postoperatively (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.