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OpenTrials
Completed

NCT Number: NCT04675840

Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Is there any difference in the intensity of postoperative pain, nausea, urinary retention and legth of hospital stay in patients undergoing robotic assisted laparoscopic surgery if they receive intrathecal morphine or peroral and intravenous opiates during the surgery and is there a significant difference in the need of opiates after the surgery.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia & Intensive Care

Karlstad, Värmland County, 65181, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients accepted for robotic-assisted laparoscopic surgery

Exclusion criteria

  • Coagulopathy,
  • Prior spine surgery,
  • Chronic pain problems,
  • Drug abuse,
  • Pregnancy
  • < 18 years

Treatment and study plan

Robotic-assisted hysterectomy

Procedure

Robotic-assisted surgery

Primary outcomes

  1. Postop morphine consumption

    Time frame: First 48 hours after surgery

    Amount of opiates given postop

  2. Postop grade of nausea & vomiting

    Time frame: First 24 hours after surgery

    Amount of antemetics given

Secondary outcomes

  1. Hospital length of stay.

    Time frame: Up to 7 days

    Time from surgery (day 0) until Fit For Discharge FFD, defined as: 1) is taking oral pain medication only; 2) is able to walk around independently; 3) is tolerating full oral diet and have bowel movements; 4) is hemodynamically an respiratory stable; 5) has no drains or urinary catheter.

  2. Patient overall satisfaction score.

    Time frame: Up to 7 days.

    1-10, where 1 is unsatisfied and 10 is very satisfied.

Sponsors and collaborators

Lead sponsor

Karlstad Central Hospital

Other

Registry information

Official study title

Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy- a Prospective Randomized Controlled Study.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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