Acute Post-operative Pain in Colon Resections (ERAS-PO)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03403842 |
|
Recruitment Status : Unknown
Verified February 2019 by Marco Gemma, IRCCS San Raffaele.
Recruitment status was: Recruiting
First Posted : January 19, 2018
Last Update Posted : February 7, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Analgesia | Device: Sublingual sufentanil tablet system Device: Peridural catheter Drug: PCA Morphine | Not Applicable |
159 patients undergoing laparoscopic colon resections will be enrolled and randomized in three different groups.
Patients in the first group will be subjected to the positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2%99 ml+sufentanil 50 mcg at an infusion rate of 4-6 ml/h.
In the second group participants will receive an intraoperative bolus of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of endovenous morphine (injection dose 1 mg,lock-out 10 minutes,maximum morphine dosage for hour 4 mg).
In the third group the investigators will adopt an intraoperative bouls of morphine (0,05mg/kg) and post-operatively a patient controlled analgesia of sufentanil sublingual tablets( 15 mcg, lock-out 20 minutes)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 159 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Acute Post-operative Pain in Patients Undergoing Laparoscopic Colon Resections |
| Actual Study Start Date : | February 1, 2018 |
| Estimated Primary Completion Date : | August 1, 2019 |
| Estimated Study Completion Date : | August 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: PERIDURAL
Peridural catheter positioning with a continuous infusion of ropivacaine 0,2% 99 ml+ sufentanil 50 mcg at an infusion rate of 4-6 ml/h
|
Device: Peridural catheter
Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg |
|
Active Comparator: PCA MORPHINE
Patient controlled analgesia of endovenous morphine, injection dose 1 mg, lock-out time 10 minutes, maximum dosage for hour 4 mg
|
Drug: PCA Morphine
Administration of endovenous morphine with a PCA |
|
Experimental: SSTS
Patients controlled analgesia of sublingual sufentanil tablet system, 15 mcg sufentanil tablets, lock out time 20 minutes
|
Device: Sublingual sufentanil tablet system
Administration of sublingual sufentanil with a PCA
Other Name: Zalviso |
- Pain intensity change in the post-operative period depending on the adopted analgesic treatment [ Time Frame: NRS will be evaluated in recovery room at 30 minutes after the end of surgery and at 6-24-48-72 hours after the end of surgery or until to the end of the proposed analgesic treatment ]The intensity of acute post-operative pain will be evaluated ,according NRS(numerical rating scale) by our Acute pain Service.NRS is a 11 point scale for patient self-reporting of pain, where zero represents no pain and ten is considered as the worst pain ever possible
- Side effects [ Time Frame: The onset of possible side effects will be monitored from randomization until to the end of the proposed analgesic treatment, assessed up to 72 hours ]Evaluation of possible side effects according to the technique adopted
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age>18 Patients undergoing laparoscopic colon resections/ Acceptance informed consent
Exclusion Criteria:
- Contraindications to the positioning of a peridural catheter/ Previous allergic reactions to the drugs used in the study/ inability of using patient controlled analgesia system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403842
| Contact: stefano turi, md | 0226432656 | turi.stefano@hsr.it | |
| Contact: marco gemma, md | 0226432656 | gemma.marco@hsr.it |
| Italy | |
| S. Raffaele Hospital | Recruiting |
| Milano, MI, Italy, 20132 | |
| Contact: Marco Gemma, MD ++390226432656 gemma.marco@hsr.it | |
| Principal Investigator: stefano turi, MD | |
| Responsible Party: | Marco Gemma, Principal Investigator, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT03403842 |
| Other Study ID Numbers: |
125/INT/2017 |
| First Posted: | January 19, 2018 Key Record Dates |
| Last Update Posted: | February 7, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Sufentanil Morphine Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |