Postoperative PainMORPHLAPCHOLNCT06182111
Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy
An observational study of Postoperative Pain and Morphine, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are: Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery? Does a… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postoperative Pain, Morphine, Laparoscopic Cholecystectomy
- What is being tested?
- Intraoperative morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2024to 31 Oct 2025
- Phase
- Observational
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.
Who may be able to join
- patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery
Who cannot join
- age limit as above
- patients unable to give consent to anesthesia
- patients unable to participate in pain scoring
- patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)
- patients with active or previous substance abuse
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Jonas L Herping, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Hospital of south West Jutland
Esbjerg, 6700
Sanne Vibe Nielsen, MD, sanne.vibe.nielsen@rsyd.dk
About this study
Official title: Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study
The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:
- Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery?
- Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.
Read the detailed description
The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.
No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.
The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.
- Conditions
- Postoperative Pain, Morphine, Laparoscopic Cholecystectomy
- Being tested
- Intraoperative morphine
- Keywords
- Intraoperative morphine for laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative morphineProcedure or surgery
Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery
| Study group | Role | What they receive |
|---|---|---|
| No morphine | Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery. | |
| Morphine | Participants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery. Receives: Procedure: Intraoperative morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of rescue analgesia.
Calculated as morphine equivalents.
Measured: 24 hours
Secondary outcomes (9)
Intraoperative opioid use.
Calculated as morphine equivalents.
Measured: 24 hours
Pain-score at arrival in postoperative ward.
Intervals: 0 = no pain, 1 = light pain (equivalent to numerical ranking scale (NRS) 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).
Measured: 24 hours
Pain-score at discharge from postoperative ward.
Intervals: 0 = no pain, 1 = light pain (equivalent to NRS 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).
Measured: 24 hours
Rescue antiemetic treatment in postoperative ward.
Antiemetic drugs and doses registered.
Measured: Up to 24 hours follow up.
Time in postoperative ward.
Minutes.
Measured: 24 hours
Analgesic treatment in surgical ward if admitted
Only if admitted (a large proportion of patients expected to undergo out-patient procedure). Calculated as morphine equivalents.
Measured: 24 hours
Antiemetic treatment in surgical ward.
Only if admitted (a large proportion of patients are expected to undergo out-patient procedure). Antiemetic drugs and doses registered.
Measured: 24 hours
Hospital length of stay.
Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).
Measured: 1 month
Emergence from anesthesia.
Surrogate measure of emergence from anesthesia time.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanne Vibe Nielsen, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Sanne V Nielsen, MD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182111
- Sponsor's protocol ID
- 23/47526
- Acronym
- MORPHLAPCHOL
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: At this time implications of answering in the affirmative are unknown, and description of shared individual participant data (IPD)s cannot be done yet. However, the investigators fully expect to share anonymized IPD in order to be able to publish the results ogf the study in a peer reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study
- ClinicalTrials.gov ID
- NCT06182111
- Acronym / sponsor ID
- MORPHLAPCHOL / 23/47526
- Conditions
- Postoperative Pain, Morphine, Laparoscopic Cholecystectomy
- Keywords
- Intraoperative morphine for laparoscopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 26 Dec 2023 (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.
The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:
- Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery?
- Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.
Detailed description
The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.
No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.
The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No morphine | – | –Participants who have undergone surgery before anesthesia protocol was changed. These participants have not received morphine during surgery. |
| Morphine | – | Procedure: Intraoperative morphineParticipants who have undergone surgery after anesthesia protocol was changed. These participants have received morphine during surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.
Key inclusion criteria (1 listed)
- patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery
Key exclusion criteria (6 listed)
- age limit as above
- patients unable to give consent to anesthesia
- patients unable to participate in pain scoring
- patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)
- patients with active or previous substance abuse
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 |
|---|---|---|
| Intraoperative morphineMorphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery | Procedure or surgery | Morphine |
Primary outcome
Use of rescue analgesia.
Time frame: 24 hours
Calculated as morphine equivalents.
9 secondary outcomes
Intraoperative opioid use.
Time frame: 24 hours
Pain-score at arrival in postoperative ward.
Time frame: 24 hours
Pain-score at discharge from postoperative ward.
Time frame: 24 hours
Rescue antiemetic treatment in postoperative ward.
Time frame: Up to 24 hours follow up.
Time in postoperative ward.
Time frame: 24 hours
Analgesic treatment in surgical ward if admitted
Time frame: 24 hours
Antiemetic treatment in surgical ward.
Time frame: 24 hours
Hospital length of stay.
Time frame: 1 month
Emergence from anesthesia.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided. At this time implications of answering in the affirmative are unknown, and description of shared individual participant data (IPD)s cannot be done yet. However, the investigators fully expect to share anonymized IPD in order to be able to publish the results ogf the study in a peer reviewed journal.
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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.
Jonas L Herping, MD contact
Sanne V Nielsen, MD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Morphine, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne V Nielsen, MD (+45 28 49 18 25 (private), sanne.vibe.nielsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of rescue analgesia. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.