NCT07629323

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

March 10, 2026

Last Update Submit

June 4, 2026

Conditions

Perioperative Pain ManagementGastreoesophageal Reflux Disease

Keywords

Laparoscopic fundoplicatio, intrathecal opioids

Outcome Measures

Primary Outcomes (3)

  • Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication.

    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.

    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: 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.

    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

Study Arms (3)

Intrathecal Fentanyl 20ug

ACTIVE COMPARATOR

Preoperative spinal with 20ug Fentanyl

Procedure: Fentanyl Intrathecal 20ug

Intrathecal Morphine 100ug

ACTIVE COMPARATOR

Preoperative Spinal with 100ug Morhine.

Drug: Intrathecal Morphine 100ug

Intravenous Morphine analgesia

OTHER

NOL- guided Intravenous Morphine analgesia

Other: NOL-guided intravenous morphine analgesia

Interventions

Fentanyl Intrathecal 20ugPROCEDURE

Intrathecal Fentanyl

Intrathecal Fentanyl 20ug
NOL-guided intravenous morphine analgesiaOTHER

NOL guided intravenous morphine analgesia

Also known as: intravenous morphine, Control
Intravenous Morphine analgesia
Intrathecal Morphine 100ugDRUG

Norhine 100ug intrathecal

Also known as: Morphine 100ug intrathecal
Intrathecal Morphine 100ug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Age \< 18 years
  • Chronic pain problems or abuse.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia & Intensive Care, Central Hospital of Karlstad

Karlstad, Värmland County, 65229, Sweden

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

June 5, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

SE(1)