Opioid-Related DisordersNCT04675840
Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy.
A study testing Robotic-assisted hysterectomy in people with Opioid-Related Disorders, run by Karlstad Central Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Robotic-assisted hysterectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients accepted for robotic-assisted laparoscopic surgery
Who cannot join
- Coagulopathy,
- Prior spine surgery,
- Chronic pain problems,
- Drug abuse,
- Pregnancy
- < 18 years
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesia & Intensive Care
Karlstad, Värmland County, 65181
About this study
Official title: 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Robotic-assisted hysterectomy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted hysterectomyProcedure or surgery
Robotic-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| intrathecal morphine | Active comparator | Spinal injection of 15mg Bupivakain and 0,25mg morphine before surgery. Receives: Procedure: Robotic-assisted hysterectomy |
| opiate po/iv | Active comparator | Patient given 10mg Oxycodone orally before surgery. Receives: Procedure: Robotic-assisted hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postop morphine consumption
Amount of opiates given postop
Measured: First 48 hours after surgery
Postop grade of nausea & vomiting
Amount of antemetics given
Measured: First 24 hours after surgery
Secondary outcomes (2)
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.
Measured: Up to 7 days
Patient overall satisfaction score.
1-10, where 1 is unsatisfied and 10 is very satisfied.
Measured: Up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Nov 2020
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karlstad Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragnar Henningsson, Karlstad Central Hospital
- Investigators
- Ragnar N Henningsson, Associate Professor, Principal investigator, Dpt of Anesthesiology & Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675840
- Sponsor's protocol ID
- KarlstadCH
- Status last verified
- Dec 2023
- First submitted
- 11 Nov 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37073442
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine for Robotic-assisted Laparoscopic Hysterectomy- a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04675840
- Acronym / sponsor ID
- KarlstadCH
- Conditions
- Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karlstad Central HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal morphine | Active comparator | Procedure: Robotic-assisted hysterectomySpinal injection of 15mg Bupivakain and 0,25mg morphine before surgery. |
| opiate po/iv | Active comparator | Procedure: Robotic-assisted hysterectomyPatient given 10mg Oxycodone orally before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients accepted for robotic-assisted laparoscopic surgery
Key exclusion criteria (6 listed)
- Coagulopathy,
- Prior spine surgery,
- Chronic pain problems,
- Drug abuse,
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted hysterectomyRobotic-assisted surgery | Procedure or surgery | intrathecal morphine, opiate po/iv |
Primary outcome
Postop morphine consumption
Time frame: First 48 hours after surgery
Amount of opiates given postop
Postop grade of nausea & vomiting
Time frame: First 24 hours after surgery
Amount of antemetics given
2 secondary outcomes
Hospital length of stay.
Time frame: Up to 7 days
Patient overall satisfaction score.
Time frame: Up to 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 37073442Engstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnar N Henningsson, Associate Professor principal investigator
Dpt of Anesthesiology & Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted hysterectomy in people with Opioid-Related Disorders, run by Karlstad Central Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postop morphine consumption (time frame: First 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04675840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.