Abdominal HysterectomyPhase 4PoPuLARNCT01492075
A Comparison Between Continuous and Intermittent Intraabdominal Analgesia Using Local Anaesthetics
A Phase 4 study testing PCRA (Intermittent injection) in people with Abdominal Hysterectomy, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- PCRA (Intermittent injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jun 2010
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 -65 year old patients undergoing open abdominal hysterectomy.
- ASA I - II (Appendix 1).
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Who cannot join
- Patients undergoing open abdominal hysterectomy due to suspected cancer.
- Patients with chronic pain who are taking analgesics regularly.
- Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Postoperative Pain Management
The investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.
Read the detailed description
Open abdominal hysterectomy is a common procedure performed for many benign and malignant gynaecological diseases and is associated with moderate to severe pain. Traditional methods for postoperative pain management include patient controlled intravenous analgesia (PCA) using morphine, epidural analgesia and spinal analgesia with opiates but recently, even local aesthetic (LA) has been used intra-abdominally and into the abdominal wall. Although epidural analgesia may be considered by some to be gold standard for pain relief following abdominal surgery, a recent publication and past experience over several years may question the use of invasive techniques for lower abdominal surgery. Thus, there is a trend towards movement from central blocks towards other non-invasive methods for pain relief.
PCA with morphine is now commonly used for management of pain following major surgery and compared to central blocks, has advantages in being relatively safe, easy to use and associated with a high degree of patient satisfaction. However, the large doses of morphine necessary to ensure adequate postoperative analgesia means that side effects such as postoperative nausea and vomiting (PONV), tiredness, pruritus, headache and constipation may be a major problem in this group of patients. Therefore, alternative techniques to reduce morphine requirements are increasingly being used. These include the use of paracetamol, non-steroidal anti-inflammatory drugs (NSAID) and recently local anaesthetics (LA). The latter have been found to result in morphine sparing by 30 - 40 % and even a reduction in postoperative nausea (PON). LA infused intraperitoneally is safe and effective and a recent study showed that using 12.5 mg/h levobupivacaine could attain adequate analgesia. Thus, efficacy of LA has been established as well as the dose. However, the method of administration of LA intraperitoneally remains unclear.
This study is designed with the primary aim of studying whether morphine consumption can be reduced postoperatively using the patient-controlled administration system for intraperitoneal LA compared to a continuous infusion, and whether this translates into improved recovery parameters or reduced side effects and improved patient satisfaction.
- Conditions
- Abdominal Hysterectomy
- Being tested
- PCRA (Intermittent injection)
- Keywords
- Postoperative pain, Anesthetics: Local anesthetics, Surgery: Hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRA (Intermittent injection)Drug
Intermittent injection of LA intraabdominally
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Active comparator | Continuous infusion of LA intraabdominally Receives: Drug: PCRA (Intermittent injection) |
| PCRA (Intermittent injection) | Experimental | Patient controlled LA intraabdominally Receives: Drug: PCRA (Intermittent injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total morphine consumption 0 - 24 h postoperatively
Measured: 0-24 h
Secondary outcomes (3)
Postoperative pain
Post-operative pain assessed on the basis of NRS (Numeric Rating Score).
Measured: 0 - 48 h postoperatively
PONV
Incidence of nausea and vomiting and anti-emetic requirement
Measured: 0 - 48 h postoperatively
Home discharge
Time to home readiness and time to return to work.
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal HysterectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
- Investigators
- Andrea Perniola, MD, Principal investigator, Örebro University, SwedenAnil Gupta, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492075
- Sponsor's protocol ID
- 20100101
- Acronym
- PoPuLAR
- Status last verified
- Sep 2015
- First submitted
- 7 Oct 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT01492075
- Acronym / sponsor ID
- PoPuLAR / 20100101
- Conditions
- Abdominal Hysterectomy
- Keywords
- Postoperative pain, Anesthetics: Local anesthetics, Surgery: Hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Dec 2011 (estimated)
- 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 investigators hypothesis is that patient controlled local anesthetics administered intraabdominally are more efficacious compared to continuous infusion in reducing postoperative pain and morphine consumption.
Detailed description
Open abdominal hysterectomy is a common procedure performed for many benign and malignant gynaecological diseases and is associated with moderate to severe pain. Traditional methods for postoperative pain management include patient controlled intravenous analgesia (PCA) using morphine, epidural analgesia and spinal analgesia with opiates but recently, even local aesthetic (LA) has been used intra-abdominally and into the abdominal wall. Although epidural analgesia may be considered by some to be gold standard for pain relief following abdominal surgery, a recent publication and past experience over several years may question the use of invasive techniques for lower abdominal surgery. Thus, there is a trend towards movement from central blocks towards other non-invasive methods for pain relief.
PCA with morphine is now commonly used for management of pain following major surgery and compared to central blocks, has advantages in being relatively safe, easy to use and associated with a high degree of patient satisfaction. However, the large doses of morphine necessary to ensure adequate postoperative analgesia means that side effects such as postoperative nausea and vomiting (PONV), tiredness, pruritus, headache and constipation may be a major problem in this group of patients. Therefore, alternative techniques to reduce morphine requirements are increasingly being used. These include the use of paracetamol, non-steroidal anti-inflammatory drugs (NSAID) and recently local anaesthetics (LA). The latter have been found to result in morphine sparing by 30 - 40 % and even a reduction in postoperative nausea (PON). LA infused intraperitoneally is safe and effective and a recent study showed that using 12.5 mg/h levobupivacaine could attain adequate analgesia. Thus, efficacy of LA has been established as well as the dose. However, the method of administration of LA intraperitoneally remains unclear.
This study is designed with the primary aim of studying whether morphine consumption can be reduced postoperatively using the patient-controlled administration system for intraperitoneal LA compared to a continuous infusion, and whether this translates into improved recovery parameters or reduced side effects and improved patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Active comparator | Drug: PCRA (Intermittent injection)Continuous infusion of LA intraabdominally |
| PCRA (Intermittent injection) | Experimental | Drug: PCRA (Intermittent injection)Patient controlled LA intraabdominally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 -65 year old patients undergoing open abdominal hysterectomy.
- ASA I - II (Appendix 1).
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Key exclusion criteria (4 listed)
- Patients undergoing open abdominal hysterectomy due to suspected cancer.
- Patients with chronic pain who are taking analgesics regularly.
- Allergy to components in levobupivacaine (Chirocaine)/Saline (Sodium Chloride).
- Participation in other clinical trials.
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 |
|---|---|---|
| PCRA (Intermittent injection)Intermittent injection of LA intraabdominally | Drug | Continuous infusion, PCRA (Intermittent injection) |
Primary outcome
Morphine consumption
Time frame: 0-24 h
Total morphine consumption 0 - 24 h postoperatively
3 secondary outcomes
Postoperative pain
Time frame: 0 - 48 h postoperatively
PONV
Time frame: 0 - 48 h postoperatively
Home discharge
Time frame: 0-10 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 29 Sep 2015.
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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.
Andrea Perniola, MD principal investigator
Örebro University, Sweden
Anil Gupta, PhD principal investigator
Örebro University, Sweden
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 PCRA (Intermittent injection) in people with Abdominal Hysterectomy, run by Örebro University, Sweden 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 4 inclusion and 4 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 29 Sep 2015. 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.
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?
Morphine consumption (time frame: 0-24 h). 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 29 Sep 2015; AzTrials last refreshed its copy on 29 Oct 2026.