Trial Title:
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
NCT ID:
NCT06595329
Condition:
Pain
Renal Cancer
Surgical Procedure, Unspecified
Conditions: Official terms:
Kidney Neoplasms
Morphine
Conditions: Keywords:
Pain management
open nephrectomy
renal cell carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
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. A person designated for data analysis will
be blinded for intervention performed in each group.
Intervention:
Intervention type:
Procedure
Intervention name:
Epidural analgesia
Description:
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.
Arm group label:
Epidural analgesia
Intervention type:
Procedure
Intervention name:
Intrathecal opioid analgesia
Description:
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.
Arm group label:
Intrathecal opioid analgesia
Other name:
Intrathecal morphine analgesia
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 9, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University Hospital of Split
Agency class:
Other
Source:
University Hospital of Split
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595329
