Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675840
• Other study ID #: KarlstadCH
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2023
• Source: Karlstad Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria:

• Coagulopathy,

• Prior spine surgery,

• Chronic pain problems,

• Drug abuse,

• Pregnancy

• < 18 years

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Procedure:
• Robotic-assisted hysterectomy
Robotic-assisted surgery

Locations

Country	Name	City	State
Sweden	Department of Anesthesia & Intensive Care	Karlstad	Värmland

Sponsors (1)

Lead Sponsor	Collaborator
Karlstad Central Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postop morphine consumption	Amount of opiates given postop	First 48 hours after surgery
Primary	Postop grade of nausea & vomiting	Amount of antemetics given	First 24 hours after surgery
Secondary	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
Secondary	Patient overall satisfaction score.	1-10, where 1 is unsatisfied and 10 is very satisfied.	Up to 7 days.