Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.

Condition(s) studied

Investigational drug(s) / intervention(s)

Fentanyl Intrathecal 20ug: Intrathecal Fentanyl

NOL-guided intravenous morphine analgesia: NOL guided intravenous morphine analgesia

Intrathecal Morphine 100ug: Norhine 100ug intrathecal

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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.
  1. Primary outcome measure: Total perioperative opioid consumtion converted to morphine equivalents. 2. Secondary outcome measure: Patient pain scores (NRS 1-10) when arriving at the PACU, when leaving the PACU and the highest pain score in the PACU.
• 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. — From inclusion to the day after surgery.
  Secondary outcomes: 1. Total intraoperative opioid dose and postoperative opioid and other analgesic requirements during the first 24 hours. 2. Postoperative nausea (0-10 scale). 3. Need for antiemetic treatment postoperatively. Length of hospital stay (days). 8\. Need for urinary catheterization (indwelling catheter or intermittent catheterization) within 24 hours postoperatively or at discharge.
• "Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0" — "From enrollment to the end of treatment at the day after surgery
  Paricipants arriving at the PACU with pain score according to the Visual Analogue Scale (VAS) \> 3

Trial sites (1)

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