Morphine Clinical Trial
Official title:
Comparison of Intrathecal Morphine, Epidural Bupivacaine With Sufentanil and Systemic Patient Controlled Analgesia With Morphine for Analgesia After Colorectal Surgery: Prospective Randomised Study.
The purpose of this study is to determine which postoperative analgesia is optimal after colorectal surgery. The investigators will compare intrathecal morphine, continuous epidural analgesia and standard systemic analgesia. All patients will have the possibility to administer themselves intravenous morphine as needed.
Introduction
Colorectal surgery is a frequent operation with expected strong post-operative pain. Thoracic
epidural analgesia is a preferred method by many authors, but it is not without risks. As
patients in our hospital usually stay at a surgical ICU for 24 hours only and epidural
infusion of opioids is prohibited at standard wards according to our hospital standards, it
seems to be too demanding method. Systemic analgesia with strong opioids is usually an
alternative, but high doses of opioids are known to cause side effects. The last possibility
is a single-shot intrathecal injection of morphine which demonstrated long-lasting analgesia
after various procedures. The main advantage is easy technique, absence of catheters and low
cost. There are not enough studies to decide which method is the most convenient. The purpose
of this prospective randomized open clinical study is to determine which postoperative
analgesia is optimal after colorectal surgery. The investigators will compare intrathecal
morphine, continuous epidural analgesia and compare both methods to standard systemic
analgesia. All patients will have the possibility to administer themselves intravenous
morphine as needed.
Hypotheses
1. Intrathecal morphine is non-inferior to continuous epidural analgesia
2. ] Intrathecal morphine will decrease the need for i.v. systemic patient controlled
analgesia (PCA) with morphine
Aims of the study
Primary aims
1. To demonstrate non-inferiority of analgesia with intrathecal morphine 0.3mg compared to
continuous epidural analgesia with 8 ml/hour of mixture of bupivacaine 0.125% and
sufentanil 0,4ug/ml. Non-inferiority is defined as consumption of PCA morphine during 24
and 72 hours not higher than 10% compared to control group.
2. To demonstrate significantly lower consumption (at least 10%) of PCA morphine in
patients with intrathecal morphine 0.3 mg compared to systemic analgesia with PCA
morphine only.
Secondary aims
1. To demonstrate similar or lower side effects of intrathecal morphine compared to
epidural or systemic analgesia. The investigators will record number of patients with
respiratory rate <8/min, SpO2<90%, changes of blood pressure and pulse rate > 30% above
base level before surgery, episodes of postoperative nausea and vomiting
2. To demonstrate the same or shorter interval since surgery to the first bowel movement
confirmed by auscultation and interval to the first flatus.
3. To demonstrate the same or lower pain intensity in patients with intrathecal morphine
compared to other two groups. The effect will be measured by area below visual analogue
scale (0 - 10) pain intensity after 24 and 72 hours
Duration of the study: Three days
Method
Design: Study will be performed as prospective randomized open clinical study
Setting: Surgical ICU
Inclusion criteria: Patients with elective colorectal surgery (left or right hemicolectomy,
subtotal colectomy, resection of sigmoid, rectal or cecum)
Exclusion criteria: Known allergy to any of drugs used, coagulopathy, sepsis, cognitive
dysfunction and/or inability to understand instruction. Pregnancy (is assessed as a part of
pre-operative examination). Abuse of drugs or administration of morphine therapy 5 or less
days before surgery. Idiopathic bowel disease.
Anesthesia: General anesthesia will be performed in all groups using propofol for induction
and rocuronium for intubation and muscle relaxation. Patients will be ventilated to
normocapnia by oxygen + air + desflurane mixture. Sufentanil 5 - 10 mcg will be administered
if needed. Paracetamol 1 g i.v. will be administered approximately 30 min before the end of
anesthesia and ondansetron 4 mg i.v. will be administered 10 min. before the end of
anesthesia. At the end of anesthesia patients will be administered atropine and neostigmine
to obtain TOF ration >90%.
Standard postoperative analgesia: All patients will be administered paracetamol 1g i.v. every
6 h for next 72 hours and can use PCA morphine, bolus dose 1 mg, lock-out interval 5 min. for
3 days at surgical ICU.
Monitoring: Except of standard anesthesia and ICU monitoring (ECG, pulse oximetry and
non-invasive blood pressure) pain intensity (VAS 0 - 10) and side effects (see above) will be
recorded.
Power analysis: Total number of patients to demonstrate primary aims is 75 divided in ratio
1:2:2; n=15 in systemic analgesia group (PCA) and n=30 in each group with epidural and
intrathecal analgesia. Standard tests will be used to analyse results. P value < 0.05 will be
considered significant.
Interventions:
1. Systemic analgesia: Patients will be administered standard general anesthesia. After
surgery, bolus doses of morphine 2 mg will be administered until level of pain will be <
4 (VAS 0 - 10). Analgesia will be continued by PCA device using morphine, bolus dose 1
mg, lock-out interval 5 min. for 3 days at surgical ICU.
2. Epidural analgesia: An epidural catheter will be inserted before induction of anesthesia
in a sitting position between T9 and T10 - T12 and L1 vertebrae. A test dose of 4 ml 0.5
bupivacaine will be administered to rule out intravascular injection or subarachnoid or
subdural block. Standard general anesthesia will be performed. Thirty minutes before the
end of the surgery, patients will be administered a bolus of a mixture of bupivacaine
0.5% (3 ml) + sufentanil 10 mcg (2 ml) + NS 5 ml followed by a continuous infusion of a
mixture containing in 1 ml bupivacaine 0.125% and sufentanil 0.4 mcg at 8 ml/h. At the
same time patients will have the possibility to use PCA device with morphine, bolus dose
1 mg, lock-out interval 5 min for 3 days at a surgical ICU. Epidural infusion will be
stopped 24 hours after surgery.
3. Intrathecal analgesia: An intrathecal administration of preservative-free morphine 0.3
mg in 3 ml NS prepared in sterile ampoules by a hospital pharmacy will be performed
before induction of anesthesia in a sitting position between L2 and L3 - L4/L5
vertebrae. Standard general anesthesia will be performed. After surgery, the patients
will have the possibility to use PCA device with morphine, bolus dose 1 mg, lock-out
interval 5 min for 3 days at a surgical ICU.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02924974 -
Spinal Morphine in Robotic Assisted Radical Prostatectomy
|
Phase 4 | |
Recruiting |
NCT03257319 -
Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
|
Phase 3 | |
Completed |
NCT04473508 -
Erectus Nerve Block for Lumbar Spine Surgery
|
Phase 3 | |
Completed |
NCT02942550 -
Methylnaltrexone as a Method to Improve Ticagrelor Uptake in Morphine Treated STEMI Patients
|
Phase 4 | |
Completed |
NCT01097148 -
Peri -and Postoperative Drug Therapy Schedules for Morbidly Obese Patients
|
Phase 4 | |
Completed |
NCT04369950 -
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
|
Phase 4 | |
Not yet recruiting |
NCT05843344 -
Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
|
N/A | |
Completed |
NCT03231683 -
Use of S+Ketamine During Target-Controlled Intravenous Anaesthesia After Abdominal Hysterectomy
|
Phase 2 | |
Completed |
NCT05654363 -
Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy
|
||
Completed |
NCT01235637 -
Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
|
Phase 3 | |
Completed |
NCT03425084 -
Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics
|
Phase 1 | |
Completed |
NCT04672382 -
Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine
|
N/A | |
Terminated |
NCT03846102 -
MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
|
Phase 4 | |
Completed |
NCT02622022 -
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
|
Phase 4 | |
Completed |
NCT04115462 -
A Relation of Morphine-induced Itch and Pain Processing
|
N/A | |
Withdrawn |
NCT04397458 -
Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
|
Phase 4 | |
Not yet recruiting |
NCT06182111 -
Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy
|
||
Recruiting |
NCT05688371 -
Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .
|
N/A | |
Terminated |
NCT03948464 -
Slow-Release Oral Morphine for the Treatment of Opioid Use Disorder
|
Phase 3 | |
Completed |
NCT02067338 -
Epidural Low Dose Morphine in Postoperative Pain After Posterior Lumbar Spinal Surgery
|
Phase 4 |