Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.

NCT ID: NCT04675840

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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intrathecal morphine

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

Group Type ACTIVE_COMPARATOR

Robotic-assisted hysterectomy

Intervention Type PROCEDURE

Robotic-assisted surgery

opiate po/iv

Patient given 10mg Oxycodone orally before surgery.

Group Type ACTIVE_COMPARATOR

Robotic-assisted hysterectomy

Intervention Type PROCEDURE

Robotic-assisted surgery

Interventions

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Robotic-assisted hysterectomy

Robotic-assisted surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\* Patients accepted for robotic-assisted laparoscopic surgery

Exclusion Criteria

* Coagulopathy,
* Prior spine surgery,
* Chronic pain problems,
* Drug abuse,
* Pregnancy
* \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karlstad Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ragnar Henningsson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragnar N Henningsson, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Dpt of Anesthesiology & Intensive Care

Locations

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Department of Anesthesia & Intensive Care

Karlstad, Värmland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 37073442 (View on PubMed)

Other Identifiers

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KarlstadCH

Identifier Type: -

Identifier Source: org_study_id