PainPhase 3LIANCT01782781
Local Infiltration Analgesia After Abdominal Hysterectomy
A Phase 3 study testing ropivacaine, ketorelac and epinephrine in people with Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- ropivacaine, ketorelac and epinephrine
- 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 2012to Oct 2014
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring abdominal hysterectomy
Who cannot join
- Body mass index > 35
- American Society of Anesthesiologists classification > 3
- Renal dysfunction
- Allergic to acetylsalicylic acid
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital
Gothenburg, SE41385
About this study
The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.
Read the detailed description
The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.
The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).
Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.
- Conditions
- Pain
- Being tested
- ropivacaine, ketorelac and epinephrine, Placebo
- Keywords
- Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, Ropivacaine, Ketorolac, Epinephrine, Adrenergic Agonists, Sympathomimetics, Therapeutic Uses, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Opioids, Morphine, Pain, Postoperative Complications, Physiological Effects of Drugs, Anesthetics, Local, Anesthetics
- Medical subject headings
- Pain, Agnosia, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine, ketorelac and epinephrineDrug
Also called Narop, Toradol and adrenaline
Active group
PlaceboDrug
Also called Saline
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Group P | Placebo comparator | Group P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv.
In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv. Receives: Drug: Placebo |
| Group A | Active comparator | Group A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv.
Drug: ropivacaine, ketorelac and epinephrine
In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv. Receives: Drug: ropivacaine, ketorelac and epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Measured: 0-24 hours postoperatively
Secondary outcomes (3)
Pain intensity (NRS, Numeric Rating Score 0-10)
Measured: 0-24 hours postoperatively
Incidence of nausea and vomiting
Measured: 0-24 hours postoperatively
Sedation intensity (Ramsey scale)
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven-Egron Thorn, MD, PhD, Principal investigator, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, SwedenAnil Gupta, MD, PhD, Study chair, Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, SwedenOve Carlsson, MD, Study chair, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, SwedenKarin Olausson, MD, Study chair, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, SwedenOlof Eckre, MD, PhD, Study chair, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, SwedenSven-Erik Ricksten, MD,PhD, Study chair, Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, SwedenFatma Backman, MD, Study chair, Dept. of Gynecological Surgery, Orebro University Hospital, Orebro, SwedenElisabeth Stadberg, MD, Study chair, Dept. of Gynecological Surgery, Sahlgrenska University Hospital, Goteborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782781
- Sponsor's protocol ID
- LIA-AH-1
- Acronym
- LIA
- Status last verified
- Oct 2014
- First submitted
- 7 Jan 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia After Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01782781
- Acronym / sponsor ID
- LIA / LIA-AH-1
- Conditions
- Pain
- Keywords
- Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, Ropivacaine, Ketorolac, Epinephrine, Adrenergic Agonists
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Feb 2013 (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 aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.
Detailed description
The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.
The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).
Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.
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 |
|---|---|---|
| Group P | Placebo comparator | Drug: PlaceboGroup P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv. In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv. |
| Group A | Active comparator | Drug: ropivacaine, ketorelac and epinephrineGroup A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv. Drug: ropivacaine, ketorelac and epinephrine In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring abdominal hysterectomy
Key exclusion criteria (5 listed)
- Body mass index > 35
- American Society of Anesthesiologists classification > 3
- Renal dysfunction
- Allergic to acetylsalicylic acid
- Unwilling to provide informed consent
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 |
|---|---|---|
| ropivacaine, ketorelac and epinephrineAlso: Narop, Toradol and adrenalineActive group | Drug | Group A |
| PlaceboAlso: SalinePlacebo group | Drug | Group P |
Primary outcome
Total morphine consumption
Time frame: 0-24 hours postoperatively
3 secondary outcomes
Pain intensity (NRS, Numeric Rating Score 0-10)
Time frame: 0-24 hours postoperatively
Incidence of nausea and vomiting
Time frame: 0-24 hours postoperatively
Sedation intensity (Ramsey scale)
Time frame: 0-24 hours postoperatively
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 21 Jan 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.
Sven-Egron Thorn, MD, PhD principal investigator
Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
Anil Gupta, MD, PhD study chair
Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
Ove Carlsson, MD study chair
Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropivacaine, ketorelac and epinephrine in people with Pain, run by Göteborg University 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 5 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 21 Jan 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Total morphine consumption (time frame: 0-24 hours 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 21 Jan 2015.