Colorectal DisordersNCT03376048
Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only
A study testing Wound infiltration plus TAP and Wound infiltration in people with Colorectal Disorders, run by Kyungpook National University Hospital at 2 sites in 2 countries.
Trial summary
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Wound infiltration plus TAP and Wound infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Dec 2017to 30 Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years, either sex
- Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
- Willingness and ability to sign an informed consent document
Who cannot join
- Allergies to anesthetic or analgesic medications
- Contraindication to the use of locoregional anesthesia
- Chronic opioid use
- Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
- Necessity of major resection other than colorectal, palliative surgery
- BMI above 35 kg/m2
- American Society of Anesthesiologists (ASA) physical status above 3
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
University of Verona Hospital Trust and Colorectal Cancer Center
Verona, 37134
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, 41404
About this study
Official title: Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Read the detailed description
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
- Conditions
- Colorectal Disorders
- Being tested
- Wound infiltration plus TAP, Wound infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltration plus TAPProcedure or surgery
Also called ropivacaine
- TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two "pops" technique).
- Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
Wound infiltrationProcedure or surgery
Also called ropivacaine
Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Wound infiltration plus TAP | Experimental | Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon Receives: Procedure: Wound infiltration plus TAP |
| Wound infiltration | Active comparator | Wound infiltration placed by surgeon Receives: Procedure: Wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain numerical rating scale (NRS)
- Pain NRS during rest and cough
- NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: within the first 6 hours after surgery
Secondary outcomes (7)
Pain NRS
- Pain NRS during rest and cough
- NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
Measured: 12, 24, 36, 48, 72 hour after surgery
Rescue opioid analgesic requirement
Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
Measured: postoperative day 0, 1, 2, 3
Postoperative nausea and vomiting scale
PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
Measured: 12, 24, 36, 48, 72 hour after surgery
Occurrence of prolonged post-operative ileus
Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)
Measured: 8 weeks after surgery
Time to first oral fluid intake
Time to first oral fluid intake after surgery
Measured: 8 weeks after surgery
Time to first oral soft diet
Time to first oral soft diet after surgery
Measured: 8 weeks after surgery
Length of hospital stay
Length of hospital stay after admission
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start20 Dec 2017
- Primary completion30 Apr 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Yeun Park, Kyungpook National University Hospital
- Investigators
- Soo Yeun Park, MD, Principal investigator, Kyungpook National University Chilgok HospitalCorrado Pedrazzani, MD, Principal investigator, University of Verona Hospital Trust and Colorectal Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376048
- Sponsor's protocol ID
- KNUHC01
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.
PubMed 32632489Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y.
PubMed 31266529
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03376048
- Acronym / sponsor ID
- KNUHC01
- Conditions
- Colorectal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Dec 2017 (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 TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Detailed description
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound infiltration plus TAP | Experimental | Procedure: Wound infiltration plus TAPWound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon |
| Wound infiltration | Active comparator | Procedure: Wound infiltrationWound infiltration placed by surgeon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-80 years, either sex
- Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
- Willingness and ability to sign an informed consent document
Key exclusion criteria (7 listed)
- Allergies to anesthetic or analgesic medications
- Contraindication to the use of locoregional anesthesia
- Chronic opioid use
- Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
- Necessity of major resection other than colorectal, palliative 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 |
|---|---|---|
| Wound infiltration plus TAPAlso: ropivacaine1. TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two "pops" technique). 2. Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision. | Procedure or surgery | Wound infiltration plus TAP |
| Wound infiltrationAlso: ropivacaineWound infiltration of ropivacaine will be performed by the surgeon before skin incision. | Procedure or surgery | Wound infiltration |
Primary outcome
Pain numerical rating scale (NRS)
Time frame: within the first 6 hours after surgery
1. Pain NRS during rest and cough 2. NRS scale 0-10: 0, "no pain"; 10, "worst pain imaginable"
7 secondary outcomes
Pain NRS
Time frame: 12, 24, 36, 48, 72 hour after surgery
Rescue opioid analgesic requirement
Time frame: postoperative day 0, 1, 2, 3
Postoperative nausea and vomiting scale
Time frame: 12, 24, 36, 48, 72 hour after surgery
Occurrence of prolonged post-operative ileus
Time frame: 8 weeks after surgery
Time to first oral fluid intake
Time frame: 8 weeks after surgery
Time to first oral soft diet
Time frame: 8 weeks after surgery
Length of hospital stay
Time frame: 8 weeks after surgery
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 5 Feb 2020.
- Derived from this study: PubMed 32632489Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.
- Derived from this study: PubMed 31266529Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y.
- 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.
Soo Yeun Park, MD principal investigator
Kyungpook National University Chilgok Hospital
Corrado Pedrazzani, MD principal investigator
University of Verona Hospital Trust and Colorectal Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound infiltration plus TAP and Wound infiltration in people with Colorectal Disorders, run by Kyungpook National University Hospital at 2 sites in 2 countries.
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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, South Korea. 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?
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?
Pain numerical rating scale (NRS) (time frame: within the first 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376048, which also lists 2 linked publications.
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 5 Feb 2020.