Post Operative PainNCT05214261
Laparoscopic-guided TAP Block vs Epidural Analgesia
A study testing Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia in people with Post Operative Pain, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2022to 31 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone
- Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)
- Urgent or emergent surgery precluding epidural catheter placement or TAP block
- Systemic Infection contraindicating epidural catheter placement or TAP block
- Rectal surgery
- Pregnant or suspected pregnancy
Show all 14Show fewer
- Age < 18 years
- Planned open surgery
- Planned bowel stoma (protective diversion and/or permanent stoma)
- Unwillingness to participate in follow-up assessments
- Patients with severe chronic pain
- Known sensibility for opioid side effects
- i.v.-PCA is contraindicated (for example drug abuse)
- No informed consent
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Surgery and Intensive Care Research Unit
Oulu, 90220
Heikki Huhta, PhD, +3583152011, heikki.huhta@ppshp.fi
Jukka Rintala, PhD, +3583152011, jukka.rintala@ppshp.fi
About this study
Official title: Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.
Read the detailed description
In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.
- Conditions
- Post Operative Pain
- Being tested
- Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesiaOther
Patients in the TAP group will be given a laparoscopic-assisted TAP block with a total of 2mg/kg of 0.25% bupivacaine in the bilateral subcostal region into four spots of the bilateral subcostal region, two on both sides of the lateral abdomen between the anterior iliac spine and lower costal arch. The TAP block is performed after the first trocar placement before the insertion of other trocars and the beginning of the surgical intervention.
In the control group epidural catheters will be placed using landmark- and loss-of-resistance techniques while the patient is on the operating table. Infusions of 4ml/h containing 0.125% levobupivacaine and 5.5 μg/mL fentanyl will be started with a CADD Solis VIP-infusion pump at the time of anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| TAP block group | Experimental | Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery Receives: Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia |
| Epidural analgesia group | Active comparator | Patients undergo epidural catheters placement for laparoscopic colorectal surgery Receives: Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery
Measured: Up to 1 month
Secondary outcomes (10)
Overall operating theatre time
Overall operating theatre time
Measured: Up to 10 hours
Post-operative morphine milligram equivalents recruitments
Post-operative morphine recruiments
Measured: Up to 1 month
Visual analogue scale
The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.
Measured: Up to 1 month
Overall benefit of analgesia score (OBAS)
The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia
Measured: Up to 1 month
Hospital readmission
Post-operative readmissions
Measured: 30 and 90-day
Time to first flatus
Post-operative flatus
Measured: Up to 1 month
Time to first bowel movement
Post-operative bowel movement
Measured: Up to 1 month
Time to post-operative mobilization
Post-operative mobilization
Measured: Up to 1 month
Overall cost-effectiveness
Overall cost-effectiveness
Measured: Up to 6 months
Post-operative complications related to interventions according to Clavien-Dindo classification
Post-operative complications
Measured: 30 and 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heikki Huhta, Oulu University Hospital
- Investigators
- Heikki Huhta, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214261
- Sponsor's protocol ID
- 112/2021
- Status last verified
- Jan 2022
- First submitted
- 16 Nov 2021
- Last updated
- 28 Jan 2022
- Results posted
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05214261
- Acronym / sponsor ID
- 112/2021
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jan 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.
The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.
Detailed description
In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block group | Experimental | Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesiaPatiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery |
| Epidural analgesia group | Active comparator | Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesiaPatients undergo epidural catheters placement for laparoscopic colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone
- Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)
- Urgent or emergent surgery precluding epidural catheter placement or TAP block
- Systemic Infection contraindicating epidural catheter placement or TAP block
- Rectal surgery
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 |
|---|---|---|
| Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesiaPatients in the TAP group will be given a laparoscopic-assisted TAP block with a total of 2mg/kg of 0.25% bupivacaine in the bilateral subcostal region into four spots of the bilateral subcostal region, two on both sides of the lateral abdomen between the anterior iliac spine and lower costal arch. The TAP block is performed after the first trocar placement before the insertion of other trocars and the beginning of the surgical intervention. In the control group epidural catheters will be placed using landmark- and loss-of-resistance techniques while the patient is on the operating table. Infusions of 4ml/h containing 0.125% levobupivacaine and 5.5 μg/mL fentanyl will be started with a CADD Solis VIP-infusion pump at the time of anesthesia induction. | Other | Epidural analgesia group, TAP block group |
Primary outcome
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
Time frame: Up to 1 month
The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery
10 secondary outcomes
Overall operating theatre time
Time frame: Up to 10 hours
Post-operative morphine milligram equivalents recruitments
Time frame: Up to 1 month
Visual analogue scale
Time frame: Up to 1 month
Overall benefit of analgesia score (OBAS)
Time frame: Up to 1 month
Hospital readmission
Time frame: 30 and 90-day
Time to first flatus
Time frame: Up to 1 month
Time to first bowel movement
Time frame: Up to 1 month
Time to post-operative mobilization
Time frame: Up to 1 month
Overall cost-effectiveness
Time frame: Up to 6 months
Post-operative complications related to interventions according to Clavien-Dindo classification
Time frame: 30 and 90-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
Heikki Huhta, PhD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia in people with Post Operative Pain, run by Oulu 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 0 inclusion and 14 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 28 Jan 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.
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 Heikki Huhta, PhD (+3583152011, heikki.huhta@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of post-operative hospital stay after elective laparoscopic colorectal surgery. (time frame: Up to 1 month). 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 Jan 2022.