Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Procedure: Robotic-assisted hysterectomy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ragnar N Henningsson, Associate Professor; Phone Number: +46708707524; Email: ragnar.henningsson@regionvarmland.se

Study Locations

• Sweden
  • Värmland
    • Karlstad, Värmland, Sweden, 65181
      • Department of Anesthesia & Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

* Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intrathecal morphine; Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery.	Procedure: Robotic-assisted hysterectomy; Robotic-assisted surgery
Active Comparator: opiate po/iv; Patient given 10mg Oxycodone orally before surgery.	Procedure: Robotic-assisted hysterectomy; Robotic-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 7 days
Patient overall satisfaction score.	1-10, where 1 is unsatisfied and 10 is very satisfied.	Up to 7 days.

Collaborators and Investigators

• Sponsor: Karlstad Central Hospital
• Investigators: Principal Investigator: Ragnar N Henningsson, Associate Professor, Dpt of Anesthesiology & Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: KarlstadCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No