Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients planned for laparoscopic Nissen fundoplication or robotic- assisted laparoscopic surgery will receive either intrathecal morphine, intrathecal fentanyl or iv morphine (control).
Perioperative total opioid consumption, Postoperative Pain Numeric Rating scale, grade of nausea and time in the postoperative ward are compared. Total grade of patient satisfaction (0-10) as well as total hospital length are also compared.
Study Description:
Background:
The field of laparoscopic and robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients can be suitable for laparoscopic surgery compared to open surgery, because of the less trauma and inflammatory response to the surgery and thereby faster recovery.
Extreme positioning of the patients as well as painful stimuli during and after surgery could still stress the circulatory response of the patient causing a mismatch in oxygen delivery and needs. Perioperative pain relief could be even more important during this type of surgery, when painful stimuli are more unpredictable.
This Study:
In this study painful stimuli during surgery are registered by the NOL pain monitor (Nociception Level) and intraoperative dosing of analgesia (remifentanil) is guided by the NOL index. NOL < 25 is accepted during surgery.
All patients receive preoperative: Acetaminophen 1g, Meclozinehydrocloride 25mg.
• Total opioid consumption during and after surgery is compared between three groups of patients receiving: Patients receiving Fentanyl intrathecal need 6 hours postoperative observation and patients receiving morphine intrathecal need 10 hours observation time.
Anesthesia: Induction of anesthesia with propofol, remifentanil and rocuronium. During surgery: Sevoflurane + remifentanil. BIS 35-50. NOL <25. Monitoring: EKG, Blood pressure, BIS (Bispectral index) and NOL. Before wake up: Parecoxib 40mg iv. Ondansetron 4mg iv. Group 1: Morphine 0,05mg/kg iv. 10 min before waking up: 1ug/kg fentanyl to all patients. Time of surgery is also registered and volume of bleeding as well.
After surgery:
NRS (Numeric Pain Scores (0-10) are registered in the PAVU when the patient is at the PACU, when leaving the PACU as well as the maximum pain score postoperative.
Total dose of opioids converted to morphine equivalents are compared between the groups as well as the pain scores and time in the PACU.
Power calculation show a need for 63 patients to receive 80% power to show a difference in morphine-equivalents between groups of 1 mgs. (p<0,05).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Fentanyl 20ug | Active Comparator | Preoperative spinal with 20ug Fentanyl |
|
| Intrathecal Morphine 100ug | Active Comparator | Preoperative Spinal with 100ug Morhine. |
|
| Intravenous Morphine analgesia | Other | NOL- guided Intravenous Morphine analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Intrathecal 20ug | Procedure | Intrathecal Fentanyl |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication. |
| From enrollment to the end of treatment - usually the day after surgery. |
| Postoperative pain assessed using the Visual Analogue Scale (VAS) upon arrival to the post-anesthesia care unit (PACU), maximum VAS score in PACU, and at discharge to ward/home/patient hotel. | Secondary outcomes:
8. Need for urinary catheterization (indwelling catheter or intermittent catheterization) within 24 hours postoperatively or at discharge. | From inclusion to the day after surgery. |
| "Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" | Paricipants arriving at the PACU with pain score according to the Visual Analogue Scale (VAS) > 3 | "From enrollment to the end of treatment at the day after surgery |
Not provided
Not provided
Inclusion Criteria: All patients scheduled for laparoscopic fundoplicatio surgery
-
Exclusion Criteria: -
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia & Intensive Care, Central Hospital of Karlstad | Karlstad | Värmland County | 65229 | Sweden |
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Randomized Controlled study
Not provided
Not provided
Not provided
| NOL-guided intravenous morphine analgesia |
| Other |
NOL guided intravenous morphine analgesia |
|
|
| Intrathecal Morphine 100ug | Drug | Norhine 100ug intrathecal |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |