Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia, Intrathecal Morphine 100ug.
- Who it may be relevant to
- Registry conditions: Perioperative Pain Management, Gastreoesophageal Reflux Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrathecal Morhine or Fentanyl Compared to Intravenous Morphine in Laparoscopic Nissen Fundoplication.
Overview
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.
Detailed description
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.
1. Preoperative: Oxycodone orally 2. Preoperative: Intrathecal Fentanyl 3. Preoperative Intrathecal Morphine. Preoperative pain assessment of the patients are Postoperative Pain from Assessment of Pain Associated with Venous Cannulation (1-10)
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).
Interventions
- Procedure Fentanyl Intrathecal 20ug
Intrathecal Fentanyl - Other NOL-guided intravenous morphine analgesia
NOL guided intravenous morphine analgesia - Drug Intrathecal Morphine 100ug
Norhine 100ug intrathecal
Primary outcome measures
- Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication. [Time frame: 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. [Time frame: From inclusion to the day after surgery.]
- "Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" [Time frame: "From enrollment to the end of treatment at the day after surgery]
Eligibility criteria
Inclusion Criteria: All patients scheduled for laparoscopic fundoplicatio surgery
\-
Exclusion Criteria: -
- Age < 18 years
- Chronic pain problems or abuse.
- Pregnancy
- Exclusion ciriteria for spinal anesthesia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Sweden · 1 center
- Department of Anesthesia & Intensive Care, Central Hospital of Karlstad — Karlstad
Identifiers
NCT: NCT07629323 · 2025-04374-01