Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedDecember 13, 2023
December 1, 2023
1.6 years
November 11, 2020
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Postop morphine consumption
Amount of opiates given postop
First 48 hours after surgery
Postop grade of nausea & vomiting
Amount of antemetics given
First 24 hours after surgery
Secondary Outcomes (2)
Hospital length of stay.
Up to 7 days
Patient overall satisfaction score.
Up to 7 days.
Study Arms (2)
intrathecal morphine
ACTIVE COMPARATORSpinal injection of 15mg Bupivakain and 0,25mg morphine before surgery.
opiate po/iv
ACTIVE COMPARATORPatient given 10mg Oxycodone orally before surgery.
Interventions
Eligibility Criteria
You may qualify if:
- \* Patients accepted for robotic-assisted laparoscopic surgery
You may not qualify if:
- Coagulopathy,
- Prior spine surgery,
- Chronic pain problems,
- Drug abuse,
- Pregnancy
- \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia & Intensive Care
Karlstad, Värmland County, 65181, Sweden
Related Publications (1)
Engstrom AJE, Ivarsson CA, Aldergard A, Henningsson RN. Analgesic effects of intrathecal morphine and bupivacaine during robotic-assisted surgery: A prospective randomized controlled study. Pain Pract. 2023 Jul;23(6):631-638. doi: 10.1111/papr.13233. Epub 2023 Apr 18.
PMID: 37073442DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ragnar N Henningsson, Associate Professor
Dpt of Anesthesiology & Intensive Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 11, 2020
First Posted
December 19, 2020
Study Start
November 1, 2020
Primary Completion
June 1, 2022
Study Completion
June 30, 2022
Last Updated
December 13, 2023
Record last verified: 2023-12