Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

Not Applicable

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Procedure: Robotic-assisted hysterectomy

• Registration Number: NCT04675840
• Lead Sponsor: Karlstad Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

* Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opiate po/iv	Robotic-assisted hysterectomy	Patient given 10mg Oxycodone orally before surgery.
intrathecal morphine	Robotic-assisted hysterectomy	Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery.

Primary Outcome Measures

Name	Time	Method
Postop grade of nausea & vomiting	First 24 hours after surgery	Amount of antemetics given
Postop morphine consumption	First 48 hours after surgery	Amount of opiates given postop

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay.	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.
Patient overall satisfaction score.	Up to 7 days.	1-10, where 1 is unsatisfied and 10 is very satisfied.

Trial Locations

Locations (1)

Department of Anesthesia & Intensive Care; 🇸🇪 Karlstad, Värmland, Sweden