Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.

Intrathecal Morhine or Fentanyl Compared to Intravenous Morphine in Laparoscopic Nissen Fundoplication.

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 Overview

• Status: Enrolling by invitation
• Conditions: Gastreoesophageal Reflux Disease; Perioperative Pain Management
• Intervention / Treatment: Procedure: Fentanyl Intrathecal 20ug; Drug: Intrathecal Morphine 100ug; Other: NOL-guided intravenous morphine analgesia

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).

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Värmland County
    • Karlstad, Värmland County, Sweden, 65229
      • Department of Anesthesia & Intensive Care, Central Hospital of Karlstad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathecal Fentanyl 20ug; Preoperative spinal with 20ug Fentanyl	Procedure: Fentanyl Intrathecal 20ug; Intrathecal Fentanyl
Active Comparator: Intrathecal Morphine 100ug; Preoperative Spinal with 100ug Morhine.	Drug: Intrathecal Morphine 100ug; Norhine 100ug intrathecal; Other Names: Morphine 100ug intrathecal
Other: Intravenous Morphine analgesia; NOL- guided Intravenous Morphine analgesia	Other: NOL-guided intravenous morphine analgesia; NOL guided intravenous morphine analgesia; Other Names: Control; intravenous morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication.	Primary outcome measure: Total perioperative opioid consumtion converted to morphine equivalents.; 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.	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: Total intraoperative opioid dose and postoperative opioid and other analgesic requirements during the first 24 hours.; Postoperative nausea (0-10 scale).; 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.	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

Collaborators and Investigators

• Sponsor: Karlstad Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic fundoplicatio, intrathecal opioids
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine
• Other Study ID Numbers: 2025-04374-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No