SurgeryPhase 4Rektus-puuNCT02869841
Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
A Phase 4 study testing Levobupivacaine continuous infusion, levobupivacaine bolus dosing and single bolus of levobupivacaine in people with Surgery and Pain Postoperative, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Pain Postoperative
- What is being tested?
- Levobupivacaine continuous infusion, levobupivacaine bolus dosing and single bolus of levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- not pregnancy/adequate contraception
- no contraindications to the local anaesthetic No contraindications to opioid patient controlled analgesia
- Informed consent obtained
Who cannot join
- • BMI >35 kg / m2
- Pregnant or breast feeding
- Contraindication to local anaesthetics
- Contraindication to opioids
- Not able to use patient controlled analgesia pump
- Relaparotomy
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.
Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.
- Conditions
- Surgery, Pain Postoperative
- Being tested
- Levobupivacaine continuous infusion, levobupivacaine bolus dosing, single bolus of levobupivacaine, Placebo
- Keywords
- laparotomy, pain, rectus sheath block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine continuous infusionDrug
Also called continuous infusion group
Levobupivacaine continuous infusion to rectus sheath catheters
levobupivacaine bolus dosingDrug
Also called bolus group
Levobupivacaine bolus dosing to rectus sheath catheters
single bolus of levobupivacaineDrug
Also called single dose group
Levobupivacaine single dose to rectus sheath catheters
PlaceboOther
Also called no rectus sheath catheters
No rectus sheath analgesia
| Study group | Role | What they receive |
|---|---|---|
| Continuous rectus sheath analgesia | Active comparator | Local anesthetic continuous infusion with infusion pumps Receives: Drug: Levobupivacaine continuous infusion |
| Bolus rectus sheath analgesia | Active comparator | Bolus administration of local anesthetic Receives: Drug: levobupivacaine bolus dosing |
| Single dose rectus sheath analgesia | Active comparator | single dose administration of local anesthetic Receives: Drug: single bolus of levobupivacaine |
| Placebo | Placebo comparator | no rectus sheath analgesia Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of rescue analgesic used for pain relief
From onset of rectus sheath analgesia
Measured: Time 0 h up to 48 h postoperatively
Secondary outcomes (2)
Maximum levobupivacaine plasma concentration
Maximum levobupivacaine plasma concentration
Measured: Time 0 h to 48 h postoperatively
maximum rescue analgesic concentration
maximum rescue analgesic concentration
Measured: time 0 h to 48 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionJul 2018
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Admescope Ltd
- Responsible party
- Sponsor
- Investigators
- Matti Eskelinen, Professor, Study chair, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869841
- Sponsor's protocol ID
- 2011-10-14
- Acronym
- Rektus-puu
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2016
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rectal Sheath Analgesia After Midline Laparotomy
- ClinicalTrials.gov ID
- NCT02869841
- Acronym / sponsor ID
- Rektus-puu / 2011-10-14
- Conditions
- Surgery, Pain Postoperative
- Keywords
- laparotomy, pain, rectus sheath block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Admescope Ltd
- Study start
- Jan 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Aug 2016 (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.
Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.
Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous rectus sheath analgesia | Active comparator | Drug: Levobupivacaine continuous infusionLocal anesthetic continuous infusion with infusion pumps |
| Bolus rectus sheath analgesia | Active comparator | Drug: levobupivacaine bolus dosingBolus administration of local anesthetic |
| Single dose rectus sheath analgesia | Active comparator | Drug: single bolus of levobupivacainesingle dose administration of local anesthetic |
| Placebo | Placebo comparator | Other: Placebono rectus sheath analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- not pregnancy/adequate contraception
- no contraindications to the local anaesthetic No contraindications to opioid patient controlled analgesia
- Informed consent obtained
Key exclusion criteria (7 listed)
- • BMI >35 kg / m2
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 |
|---|---|---|
| Levobupivacaine continuous infusionAlso: continuous infusion groupLevobupivacaine continuous infusion to rectus sheath catheters | Drug | Continuous rectus sheath analgesia |
| levobupivacaine bolus dosingAlso: bolus groupLevobupivacaine bolus dosing to rectus sheath catheters | Drug | Bolus rectus sheath analgesia |
| single bolus of levobupivacaineAlso: single dose groupLevobupivacaine single dose to rectus sheath catheters | Drug | Single dose rectus sheath analgesia |
| PlaceboAlso: no rectus sheath cathetersNo rectus sheath analgesia | Other | Placebo |
Primary outcome
Amount of rescue analgesic used for pain relief
Time frame: Time 0 h up to 48 h postoperatively
From onset of rectus sheath analgesia
2 secondary outcomes
Maximum levobupivacaine plasma concentration
Time frame: Time 0 h to 48 h postoperatively
maximum rescue analgesic concentration
Time frame: time 0 h to 48 h 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 27 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Matti Eskelinen, Professor study chair
Kuopio 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 Levobupivacaine continuous infusion, levobupivacaine bolus dosing and single bolus of levobupivacaine in people with Surgery and Pain Postoperative, run by Kuopio University Hospital at 1 site in Finland.
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 3 inclusion and 7 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 27 Oct 2023. 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 Finland. 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?
Amount of rescue analgesic used for pain relief (time frame: Time 0 h up to 48 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 27 Oct 2023.