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Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07629323
Enrollment
63
Registered
2026-06-05
Start date
2026-03-10
Completion date
2027-03-31
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastreoesophageal Reflux Disease, Perioperative Pain Management

Keywords

Laparoscopic fundoplicatio, intrathecal opioids

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.

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

PROCEDUREFentanyl Intrathecal 20ug

Intrathecal Fentanyl

OTHERNOL-guided intravenous morphine analgesia

NOL guided intravenous morphine analgesia

DRUGIntrathecal Morphine 100ug

Norhine 100ug intrathecal

Sponsors

Karlstad Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized Controlled study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 surgeryParicipants arriving at the PACU with pain score according to the Visual Analogue Scale (VAS) \> 3

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026