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Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Primary Purpose

Opioid-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Robotic-assisted hysterectomy
Sponsored by
Karlstad Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

* Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesia & Intensive CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intrathecal morphine

opiate po/iv

Arm Description

Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery.

Patient given 10mg Oxycodone orally before surgery.

Outcomes

Primary Outcome Measures

Postop morphine consumption
Amount of opiates given postop
Postop grade of nausea & vomiting
Amount of antemetics given

Secondary Outcome Measures

Hospital length of stay.
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.
Patient overall satisfaction score.
1-10, where 1 is unsatisfied and 10 is very satisfied.

Full Information

First Posted
November 11, 2020
Last Updated
April 5, 2022
Sponsor
Karlstad Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04675840
Brief Title
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.
Official Title
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy- a Prospective Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karlstad Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intrathecal morphine
Arm Type
Active Comparator
Arm Description
Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery.
Arm Title
opiate po/iv
Arm Type
Active Comparator
Arm Description
Patient given 10mg Oxycodone orally before surgery.
Intervention Type
Procedure
Intervention Name(s)
Robotic-assisted hysterectomy
Intervention Description
Robotic-assisted surgery
Primary Outcome Measure Information:
Title
Postop morphine consumption
Description
Amount of opiates given postop
Time Frame
First 48 hours after surgery
Title
Postop grade of nausea & vomiting
Description
Amount of antemetics given
Time Frame
First 24 hours after surgery
Secondary Outcome Measure Information:
Title
Hospital length of stay.
Description
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.
Time Frame
Up to 7 days
Title
Patient overall satisfaction score.
Description
1-10, where 1 is unsatisfied and 10 is very satisfied.
Time Frame
Up to 7 days.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Hysterectomy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: * Patients accepted for robotic-assisted laparoscopic surgery Exclusion Criteria: Coagulopathy, Prior spine surgery, Chronic pain problems, Drug abuse, Pregnancy < 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ragnar N Henningsson, Associate Professor
Phone
+46708707524
Email
ragnar.henningsson@regionvarmland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragnar N Henningsson, Associate Professor
Organizational Affiliation
Dpt of Anesthesiology & Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia & Intensive Care
City
Karlstad
State/Province
Värmland
ZIP/Postal Code
65181
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragnar N Henningsson, Associate Professor
Phone
+46708707524
Email
ragnar.henningsson@regionvarmland.se
First Name & Middle Initial & Last Name & Degree
Anders Engström, MD
Phone
+4654615000
Email
anders.engstrom@regionvarmland.se

12. IPD Sharing Statement

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Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

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