Postoperative PainPhase 4NCT05273281
Pain-relieving Methods After Laparoscopic Hemicolectomy
A Phase 4 study testing Transabdominal plane block and Quadratus lumborum block in people with Postoperative Pain and Nerve Block, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Effects of Transabdominal Plain Block and Quadratus Lumborum Block After Laparoscopic Hemicolectomy. The pain relief, bowel function and discharge. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Nerve Block
- What is being tested?
- Transabdominal plane block and Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2022to 1 Feb 2025
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult elective hemicolectomy patients
Who cannot join
- Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Use of drugs that significantly influences the metabolism of paracetamol or opiate Steroid medication in regular use Significant liver-, lung- or kidney disfunction
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, 33521
Maija-Liisa Kalliomäki, PhD, +358 3 311 69424, maija-liisa.kalliomaki@pshp.fi
Jenni Kanerva, PhD, +358 3 311 67415, jenni.kanerva@pshp.fi
About this study
Official title: Pain-relieving Methods After Laparoscopic Hemicolectomy, Effects of Transabdominal Plain Block and Quadratus Lumborum Block
Effects of Transabdominal Plain Block and Quadratus Lumborum Block After Laparoscopic Hemicolectomy. The pain relief, bowel function and discharge.
Read the detailed description
This study is proposed to explore the effects of transabdominal plane block and quadratus lumborum block after laparoscopic hemicolectomy.
After laparoscopic hemicolectomy there is a need for good analgesia. When the analgesia is adequate the patients mobilisation, bowel function and discharge is faster. Earlier, epidural block has been used for the analgesia but now the hemicolectomy is laparoscopic procedure and there is no need for central block anymore. Still patients needs opioids after the operation. Because of the opioids side effects, there is a need to find better analgesia methods.
In this study investigators compare peripheral nerve blocks, transabdominal plane and quadratus lumborum, for analgesia after laparoscopic hemicolectomy. Also investigators are comparing these analgesia methods and traditional orally analgesics. Patients receive transabdominal or quadratus lumborum block after induction using ropivacaine 5 mg/ml 20 ml per side. The third group is a control group witch analgesia is taken care with traditional orally analgesics.
After surgery investigators follow postoperative pain, opiate consumption, bowel function, nausea and mobilisation.
Investigators coal is to find if the transabdominal plain block or quadratus lumborum block prefer traditional analgesia methods after laparoscopic hemicolectomy.
- Conditions
- Postoperative Pain, Nerve Block
- Being tested
- Transabdominal plane block, Quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal plane blockProcedure or surgery
Peripheral nerve block
Quadratus lumborum blockProcedure or surgery
Peripheral nerve block
| Study group | Role | What they receive |
|---|---|---|
| TAQLA | Experimental | Transabdominal plain block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side. Receives: Procedure: Transabdominal plane block |
| TAQLB | Experimental | Quadratus lumborum block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side. Receives: Procedure: Quadratus lumborum block |
| TAQLC | No intervention | Control group. Pain relief only with intravenous and peroral drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 72 hours or until discharge, whichever came first
Secondary outcomes (4)
Opiate consumption
Total opiate consumption after surgery
Measured: 72 hours or until discharge, whichever came first
Post operative pain
Numeric rating scale NRS 0-10, verbally description after discharge
Measured: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Bowel function
Verbally description: non/gas/function
Measured: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Nausea
Verbally description: yes/no
Measured: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jun 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenni Kanerva, Phd, Principal investigator, Tampere University HospitalMaija-Liisa Kalliomäki, PhD, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273281
- Sponsor's protocol ID
- R21075M
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain-relieving Methods After Laparoscopic Hemicolectomy, Effects of Transabdominal Plain Block and Quadratus Lumborum Block
- ClinicalTrials.gov ID
- NCT05273281
- Acronym / sponsor ID
- R21075M
- Conditions
- Postoperative Pain, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Mar 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.
Effects of Transabdominal Plain Block and Quadratus Lumborum Block After Laparoscopic Hemicolectomy. The pain relief, bowel function and discharge.
Detailed description
This study is proposed to explore the effects of transabdominal plane block and quadratus lumborum block after laparoscopic hemicolectomy.
After laparoscopic hemicolectomy there is a need for good analgesia. When the analgesia is adequate the patients mobilisation, bowel function and discharge is faster. Earlier, epidural block has been used for the analgesia but now the hemicolectomy is laparoscopic procedure and there is no need for central block anymore. Still patients needs opioids after the operation. Because of the opioids side effects, there is a need to find better analgesia methods.
In this study investigators compare peripheral nerve blocks, transabdominal plane and quadratus lumborum, for analgesia after laparoscopic hemicolectomy. Also investigators are comparing these analgesia methods and traditional orally analgesics. Patients receive transabdominal or quadratus lumborum block after induction using ropivacaine 5 mg/ml 20 ml per side. The third group is a control group witch analgesia is taken care with traditional orally analgesics.
After surgery investigators follow postoperative pain, opiate consumption, bowel function, nausea and mobilisation.
Investigators coal is to find if the transabdominal plain block or quadratus lumborum block prefer traditional analgesia methods after laparoscopic hemicolectomy.
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 |
|---|---|---|
| TAQLA | Experimental | Procedure: Transabdominal plane blockTransabdominal plain block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side. |
| TAQLB | Experimental | Procedure: Quadratus lumborum blockQuadratus lumborum block -group. Ropivacaine Hydrochloride Inj 5mg/ml 20 ml perineurally per side. |
| TAQLC | No intervention | –Control group. Pain relief only with intravenous and peroral drugs. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult elective hemicolectomy patients
Key exclusion criteria (1 listed)
- Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Use of drugs that significantly influences the metabolism of paracetamol or opiate Steroid medication in regular use Significant liver-, lung- or kidney disfunction
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 |
|---|---|---|
| Transabdominal plane blockPeripheral nerve block | Procedure or surgery | TAQLA |
| Quadratus lumborum blockPeripheral nerve block | Procedure or surgery | TAQLB |
Primary outcome
First need of opiate
Time frame: 72 hours or until discharge, whichever came first
Time after surgery when the patient needs opiate for the first time
4 secondary outcomes
Opiate consumption
Time frame: 72 hours or until discharge, whichever came first
Post operative pain
Time frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Bowel function
Time frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Nausea
Time frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 32 hours, 40 hours, at 48 hours, at 56 hours, at 64 hours, at 72 hours, ones per day after discharge for seven days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- 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.
Jenni Kanerva, Phd principal investigator
Tampere University Hospital
Maija-Liisa Kalliomäki, PhD study director
Tampere 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 Transabdominal plane block and Quadratus lumborum block in people with Postoperative Pain and Nerve Block, run by Tampere 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maija-Liisa Kalliomäki, PhD (+358 3 311 69424, maija-liisa.kalliomaki@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First need of opiate (time frame: 72 hours or until discharge, whichever came first). 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 7 Nov 2022.