Perioperative Pain ManagementNCT07629323
Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
A study testing Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia and Intrathecal Morphine 100ug in people with Perioperative Pain Management and Gastreoesophageal Reflux Disease, run by Karlstad Central Hospital at 1 site in Sweden.
Trial summary
Patients planned for laparoscopic Nissen fundoplication or robotic- assisted laparoscopic surgery will receive either intrathecal morphine, intrathecal fentanyl or iv morphine (control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Pain Management, Gastreoesophageal Reflux Disease
- What is being tested?
- Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia and Intrathecal Morphine 100ug
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age < 18 years
- Chronic pain problems or abuse.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Anesthesia & Intensive Care, Central Hospital of Karlstad
Karlstad, Värmland County, 65229
About this study
Official title: 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.
Read the 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.
- Preoperative: Oxycodone orally
- Preoperative: Intrathecal Fentanyl
- 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).
- Being tested
- Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia, Intrathecal Morphine 100ug
- Keywords
- Laparoscopic fundoplicatio, intrathecal opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Intrathecal 20ugProcedure or surgery
Intrathecal Fentanyl
NOL-guided intravenous morphine analgesiaOther
Also called intravenous morphine, Control
NOL guided intravenous morphine analgesia
Intrathecal Morphine 100ugDrug
Also called Morphine 100ug intrathecal
Norhine 100ug intrathecal
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Fentanyl 20ug | Active comparator | Preoperative spinal with 20ug Fentanyl Receives: Procedure: Fentanyl Intrathecal 20ug |
| Intrathecal Morphine 100ug | Active comparator | Preoperative Spinal with 100ug Morhine. Receives: Drug: Intrathecal Morphine 100ug |
| Intravenous Morphine analgesia | Other | NOL- guided Intravenous Morphine analgesia Receives: Other: NOL-guided intravenous morphine analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
- Need for urinary catheterization (indwelling catheter or intermittent catheterization) within 24 hours postoperatively or at discharge.
Measured: 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
Measured: "From enrollment to the end of treatment at the day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start10 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlstad Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragnar Henningsson, Karlstad Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629323
- Sponsor's protocol ID
- 2025-04374-01
- Other IDs
- 2025
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morhine or Fentanyl Compared to Intravenous Morphine in Laparoscopic Nissen Fundoplication.
- ClinicalTrials.gov ID
- NCT07629323
- Acronym / sponsor ID
- 2025-04374-01
- Keywords
- Laparoscopic fundoplicatio, intrathecal opioids
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Karlstad Central HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Preoperative: Oxycodone orally
- Preoperative: Intrathecal Fentanyl
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled study
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Fentanyl 20ug | Active comparator | Procedure: Fentanyl Intrathecal 20ugPreoperative spinal with 20ug Fentanyl |
| Intrathecal Morphine 100ug | Active comparator | Drug: Intrathecal Morphine 100ugPreoperative Spinal with 100ug Morhine. |
| Intravenous Morphine analgesia | Other | Other: NOL-guided intravenous morphine analgesiaNOL- guided Intravenous Morphine analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Age < 18 years
- Chronic pain problems or abuse.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Intrathecal 20ugIntrathecal Fentanyl | Procedure or surgery | Intrathecal Fentanyl 20ug |
| NOL-guided intravenous morphine analgesiaAlso: intravenous morphine, ControlNOL guided intravenous morphine analgesia | Other | Intravenous Morphine analgesia |
| Intrathecal Morphine 100ugAlso: Morphine 100ug intrathecalNorhine 100ug intrathecal | Drug | Intrathecal Morphine 100ug |
Primary outcome
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.
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.
Time frame: 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"
Time frame: "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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl Intrathecal 20ug, NOL-guided intravenous morphine analgesia and Intrathecal Morphine 100ug in people with Perioperative Pain Management and Gastreoesophageal Reflux Disease, run by Karlstad Central Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.