EndometriosisPhase 4CLONIPAINNCT05560230
Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis
A Phase 4 study testing Clonidine and Isotonic saline in people with Endometriosis and Postoperative Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
The role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Postoperative Pain, Pain, Acute
- What is being tested?
- Clonidine and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2022to 13 Aug 2024
- Phase
- Phase 4
- 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 to 110 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital
Who cannot join
- Age < 18 years
- American Society of Anesthesiologists (ASA) physical status IV or V
- Allergy to clonidine
- Inability to provide informed consent
- Known severe renal insufficiency
- Known severe bradyarrhythmia
Show all 9Show fewer
- Pregnancy, lactation:
- Daily opioid consumption the last 7 days before surgery
- Pain intensity >5 on more than half of the days during the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis: a Prospective, Double-blind, Randomized Controlled Trial
The role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.
Read the detailed description
Background with aim: Acute postoperative pain is a major and common concern for the large number of patients who undergo surgery each year. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period. This is concerning as unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Effective treatment of acute postoperative pain should therefore be prioritized. Opioid analgesics remain the mainstay treatment for postoperative pain. The potential benefits of opioid therapy for acute pain are short-term pain control. However, there are several potential harms associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation and risk of long-term use. In this respect, a single dose of clonidine could provide stable analgesia and potentially reduce the need for shorter-acting opioids. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects.
Method: 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (clonidine 150 microgram) and a control arm (isotonic saline). The study will be GCP-monitored, and is approved by the Danish Medicines Agency (2022064017) and the National Committee on Health Research Ethics (2209269).
Hypothesis: The investigators hypothesize that a single dose of intraoperatively administered intravenous clonidine will be effective in reducing postoperative opioid requirements, pain intensity and opioid-related side effects.
- Being tested
- Clonidine, Isotonic saline
- Medical subject headings
- Endometriosis, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
A single dose of intraoperatively administered intravenous clonidine 150 μg will be infused over 5-10 min., immediately after intubation
Isotonic salineDrug
A single dose of administered intravenous isotonic saline will be infused over 5-10 min., immediately after intubation
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | A 100 ml isotonic saline will be mixed with 1 ml clonidine (150 μg). The blinded 100 ml bag including isotonic saline and clonidine 150 μg will be infused over 5-10 min., immediately after intubation. Receives: Drug: Clonidine |
| Isotonic saline | Placebo comparator | A 100 ml isotonic saline will be mixed with 1 ml isotonic saline. The blinded 100 ml bag including isotonic saline will be infused over 5-10 min., immediately after intubation. Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption 0-3 hours
Opioid consumption within the first 3 hours after arrival at the PACU
Measured: 3 hours after arrival at the PACU
Secondary outcomes (7)
Cumulative opioid consumption 0-6 hours
Opioid consumption within the first 6 hours after arrival at the PACU
Measured: 6 hours after arrival at the PACU
Pain intensity at rest
Pain intensity at rest (NRS; 0-10) at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Measured: 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Pain intensity during coughing
Pain intensity during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Measured: 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Shivering
Shivering at 0, 60 and 120 minutes after arrival at the PACU
Measured: 0, 60 and 120 minutes after arrival at the PACU
Sedation (Ramsey Sedation Score 1-6)
Sedation at 0, 60 and 120 minutes after arrival at the PACU
Measured: 0, 60 and 120 minutes after arrival at the PACU
PONV
Nausea and/or vomiting at 0, 60 and 120 minutes after arrival at the PACU
Measured: 0, 60 and 120 minutes after arrival at the PACU
Discharge from the PACU
Time for discharge from the PACU (hours and minutes)
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 posted29 Sep 2022
- Study start3 Oct 2022
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: Intervention arm (clonidine 150 microgram). Control arm (isotonic saline).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Lone Nikolajsen, MD, DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560230
- Sponsor's protocol ID
- 2022064017
- Acronym
- CLONIPAIN
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared upon reasonable request by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis: a Prospective, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05560230
- Acronym / sponsor ID
- CLONIPAIN / 2022064017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 29 Sep 2022 (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 role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.
Detailed description
Background with aim: Acute postoperative pain is a major and common concern for the large number of patients who undergo surgery each year. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period. This is concerning as unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Effective treatment of acute postoperative pain should therefore be prioritized. Opioid analgesics remain the mainstay treatment for postoperative pain. The potential benefits of opioid therapy for acute pain are short-term pain control. However, there are several potential harms associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation and risk of long-term use. In this respect, a single dose of clonidine could provide stable analgesia and potentially reduce the need for shorter-acting opioids. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects.
Method: 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (clonidine 150 microgram) and a control arm (isotonic saline). The study will be GCP-monitored, and is approved by the Danish Medicines Agency (2022064017) and the National Committee on Health Research Ethics (2209269).
Hypothesis: The investigators hypothesize that a single dose of intraoperatively administered intravenous clonidine will be effective in reducing postoperative opioid requirements, pain intensity and opioid-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: Intervention arm (clonidine 150 microgram). Control arm (isotonic saline).
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: ClonidineA 100 ml isotonic saline will be mixed with 1 ml clonidine (150 μg). The blinded 100 ml bag including isotonic saline and clonidine 150 μg will be infused over 5-10 min., immediately after intubation. |
| Isotonic saline | Placebo comparator | Drug: Isotonic salineA 100 ml isotonic saline will be mixed with 1 ml isotonic saline. The blinded 100 ml bag including isotonic saline will be infused over 5-10 min., immediately after intubation. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital
Key exclusion criteria (9 listed)
- Age < 18 years
- American Society of Anesthesiologists (ASA) physical status IV or V
- Allergy to clonidine
- Inability to provide informed consent
- Known severe renal insufficiency
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 |
|---|---|---|
| ClonidineA single dose of intraoperatively administered intravenous clonidine 150 μg will be infused over 5-10 min., immediately after intubation | Drug | Clonidine |
| Isotonic salineA single dose of administered intravenous isotonic saline will be infused over 5-10 min., immediately after intubation | Drug | Isotonic saline |
Primary outcome
Cumulative opioid consumption 0-3 hours
Time frame: 3 hours after arrival at the PACU
Opioid consumption within the first 3 hours after arrival at the PACU
7 secondary outcomes
Cumulative opioid consumption 0-6 hours
Time frame: 6 hours after arrival at the PACU
Pain intensity at rest
Time frame: 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Pain intensity during coughing
Time frame: 0, 30, 60, 90 and 120 minutes after arrival at the PACU
Shivering
Time frame: 0, 60 and 120 minutes after arrival at the PACU
Sedation (Ramsey Sedation Score 1-6)
Time frame: 0, 60 and 120 minutes after arrival at the PACU
PONV
Time frame: 0, 60 and 120 minutes after arrival at the PACU
Discharge from the PACU
Time frame: 24 hours
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 23 Aug 2024.
- Individual participant dataSharing planned: No. The data will be shared upon reasonable request by other researchers
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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.
Lone Nikolajsen, MD, DMSc study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine and Isotonic saline in people with Endometriosis and Postoperative Pain, run by University of Aarhus 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 9 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 23 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cumulative opioid consumption 0-3 hours (time frame: 3 hours after arrival at the PACU). 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 23 Aug 2024.