Uterine MyomaPhase 4PoPuLARNCT01492179
Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.
A Phase 4 study testing Normal saline, Intravenous Lidocaine and Intra-abdominal Lidocaine in people with Uterine Myoma and Persistent Post-menpausal Bleeding, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Uterine Myoma, Persistent Post-menpausal Bleeding, Uterine Cancer
- What is being tested?
- Normal saline, Intravenous Lidocaine and Intra-abdominal Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Jun 2013
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2
- 30 - 75 yrs
- Informed consent
- 50 - 100 kg
Who cannot join
- Allergy to LA
- Chronic pain
- Major liver/kidney insufficiency
- AV Block 1-2 Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.
Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.
Read the detailed description
Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.
Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.
- Being tested
- Normal saline, Intravenous Lidocaine, Intra-abdominal Lidocaine
- Keywords
- Surgery: Abdominal hysterectomy, Anesthetics: Local, Postoperative: Pain, Drugs: Morphine
- Medical subject headings
- Myofibroma, Uterine Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Normal saline would be administered intravenously and intra-abdominally.
Intravenous LidocaineDrug
Also called Xylocaine 5 mg/ml
Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.
Intra-abdominal LidocaineDrug
Also called Xylocaine 5 mg/ml
Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Lidocaine | Active comparator | Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively. Receives: Drug: Intravenous Lidocaine |
| Intra-abdominal Lidocaine | Active comparator | Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management. Receives: Drug: Intra-abdominal Lidocaine |
| Normal saline | Placebo comparator | Normal saline would be administered intra-abdominally and intravenously in the same patient. Rescue analgesia in the form of morphine (PCA) would be used for pain management. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
Measured: 0 - 24 h postoperatively
Secondary outcomes (3)
Postoperative pain
Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h
Measured: 4 h postoperatively
Plasma concentration of lidocaine
The plasma concentration of LA lidocaine would be analysed at 24 h in order to assess whether the LA absorption from the abdomen is similar to that administered intravenously.
Measured: 24 h
Length of Hospital stay
The time to discharge home would be assessed using standardized criteria for home discharge.
Measured: 1-5 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 startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine MyomaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gupta, Örebro University, Sweden
- Investigators
- Kjell Axelsson, MD, PhD, Study director, Örebro University Hospital, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492179
- Sponsor's protocol ID
- 20111212
- Acronym
- PoPuLAR
- Status last verified
- May 2014
- First submitted
- 12 Dec 2011
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.
- ClinicalTrials.gov ID
- NCT01492179
- Acronym / sponsor ID
- PoPuLAR / 20111212
- Keywords
- Surgery: Abdominal hysterectomy, Anesthetics: Local, Postoperative: Pain, Drugs: Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (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.
Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.
Detailed description
Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.
Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Lidocaine | Active comparator | Drug: Intravenous LidocaineIntravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively. |
| Intra-abdominal Lidocaine | Active comparator | Drug: Intra-abdominal LidocaineLidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management. |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline would be administered intra-abdominally and intravenously in the same patient. Rescue analgesia in the form of morphine (PCA) would be used for pain management. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 1-2
- 30 - 75 yrs
- Informed consent
- 50 - 100 kg
Key exclusion criteria (4 listed)
- Allergy to LA
- Chronic pain
- Major liver/kidney insufficiency
- AV Block 1-2 Participation in another clinical trial
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 |
|---|---|---|
| Normal salineNormal saline would be administered intravenously and intra-abdominally. | Drug | Normal saline |
| Intravenous LidocaineAlso: Xylocaine 5 mg/mlStandardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered. | Drug | Intravenous Lidocaine |
| Intra-abdominal LidocaineAlso: Xylocaine 5 mg/mlLidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h | Drug | Intra-abdominal Lidocaine |
Primary outcome
Morphine consumption
Time frame: 0 - 24 h postoperatively
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
3 secondary outcomes
Postoperative pain
Time frame: 4 h postoperatively
Plasma concentration of lidocaine
Time frame: 24 h
Length of Hospital stay
Time frame: 1-5 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 28 May 2014.
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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.
Kjell Axelsson, MD, PhD study director
Örebro University Hospital, Örebro, 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 Normal saline, Intravenous Lidocaine and Intra-abdominal Lidocaine in people with Uterine Myoma and Persistent Post-menpausal Bleeding, 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 28 May 2014. 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. 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?
Morphine consumption (time frame: 0 - 24 h postoperatively). 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 May 2014.