Colonic CancerNCT01339273
Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
A study testing Ultrasound guided Transversus Abdominis Plane (TAP) bock and Local anaesthetic infiltration of laparoscopic port sites in people with Colonic Cancer and Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Cancer, Rectal Cancer, Colonic Diverticulum
- What is being tested?
- Ultrasound guided Transversus Abdominis Plane (TAP) bock and Local anaesthetic infiltration of laparoscopic port sites
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Undergoing elective laparoscopic high anterior resection without stoma or laparoscopic right hemicolectomy.
- American Society of Anaesthetists physical status (ASA) 1-3
Who cannot join
- Opioid tolerance
- Chronic abdominal pain
- Allergy/Intolerance: Morphine, local anaesthetics
- BMI>35 Kg/M2
- Previous major abdominal surgery
- High likelihood of conversion to open procedure
- Patients unable to communicate in written and spoken English
- Weight less than 50 kg
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Churchill Hospital, Oxford Radcliffe Hospitals NHS trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial
Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery.
Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge.
The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)
Read the detailed description
Summary of Study Design The study will be a double blind randomised controlled trial with patients undergoing laparoscopic right hemicolectomy or laparoscopic high anterior resection randomly allocated into two groups, with the study group receiving bilateral TAP blocks followed by a morphine PCA and the control group receiving local anaesthetic infiltration of the laparoscopic port sites and specimen extraction site and a morphine PCA.
A double blind design was chosen to eliminate patient and observer bias in reporting of pain scores.
The presence of the control arm will ensure that any difference observed will be due to the effect of sensory nerve block due to the TAP block than due to the systemic effect of the injected local anaesthetic.
The null hypothesis will be that there is no difference between the groups in the amount of morphine consumed by the patients during 48 hours after the operation. We chose this measurement as an objective but indirect measurement of efficacy of TAP block and pain relief thus received. Measurement of pain with various scoring methods are reliable only when concurrent reduction in consumption of pain killers are demonstrated.
Recruitment and randomisation:
All patients meeting the inclusion criteria will receive a patient information leaflet and an invitation letter to participate in the study during the pre-assessment visit. We aim to recruit 72 patients (36 patients per group).
Informed consent will be taken by one of the investigators on the morning of the surgery, if the exclusion criteria are not applicable. Patients will be allotted consecutive participant numbers starting from one. Patients will be randomly allocated into either the study group and a control group. Randomisation will occur by using computer generated random numbers. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-6 anaesthetic room of Churchill hospital.Once patient has consented, the anaesthetist will open the corresponding numbered envelope and perform bilateral TAP blocks after induction of general anaesthesia, if the patient is in the study group the surgeons will infiltrate the port sites with local anaesthetic at the end of the procedure if the patient is in the control group.
Blinding:
The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side and the skin punctures on either sides will be covered with a small plaster. Patients in the control group will receive subcutaneous infiltration of the laparoscopic port sites and specimen extraction site with equivalent amount bupivacaine at the end of the procedure and small plasters will be stuck on either flanks approximately where the skin punctures for TAP block will be made.
The assessor of pain scores and morphine doses (Recovery nurse \& Colo-rectal house officer) and the patient will be blinded to group allocation.
Patient: Plasters will be stuck on flanks of all the patients both study and control group so that patient will not know if they have received TAP block.
Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention about group allocation.
Colo-rectal house officer: The house officers( Junior Doctors) who will be following up in the ward will not present in the operating theatre, so they will be blinded
The study duration will be from induction of anaesthesia until the patients are medically fit for discharge from hospital. No extra visits other than routinely required for the surgical procedure is expected.
- Being tested
- Ultrasound guided Transversus Abdominis Plane (TAP) bock, Local anaesthetic infiltration of laparoscopic port sites
- Keywords
- TAP block, Laparoscopic hemicolectomy, Laparoscopic anterior resection, laparoscopic colonic resection
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulum, Colon, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Transversus Abdominis Plane (TAP) bockProcedure or surgery
Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
Local anaesthetic infiltration of laparoscopic port sitesProcedure or surgery
Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | Patients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster Receives: Procedure: Ultrasound guided Transversus Abdominis Plane (TAP) bock |
| Local anaesthetic infiltration | Active comparator | Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made. Receives: Procedure: Local anaesthetic infiltration of laparoscopic port sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption in the First 48hours After the Operation
Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.
Measured: 48 hours after the operation
Secondary outcomes (13)
Numerical Rating Pain Scores at 48 Hours Postoperatively
Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain
Measured: 48 hours after the operation
Nausea Score at 48 Hours Postoperatively
0-10 0= no nausea 10=severe nausea
Measured: 48 hours after the operation
Time to First Request for Rescue Analgesia
The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Mobilisation
Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Successful Intake of Fluids
Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral fluids.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Resumption of Normal Diet
Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to First Bowel Motion
Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to First Flatus
Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Medically Fit to Discharge
Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.
Measured: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Total Morphine Consumption at 24hours
Measured: 24 hours
Nausea at 24hours Post Operatively
Measured: 24 hours
Time to Mobilization
Measured: days
Time to Hospital Discharge
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colonic CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nicholas Crabtree, Oxford University Hospitals NHS Trust
- Investigators
- Nicholas Crabtree, MB,ChB, FRCA, Principal investigator, Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339273
- Sponsor's protocol ID
- Sponsorship review number:113
- Status last verified
- Jan 2020
- First submitted
- 18 Apr 2011
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zafar N, Davies R, Greenslade GL, Dixon AR. The evolution of analgesia in an 'accelerated' recovery programme for resectional laparoscopic colorectal surgery with anastomosis. Colorectal Dis. 2010 Feb;12(2):119-24. doi: 10.1111/j.1463-1318.2009.01768.x. Epub 2009 Jan 16.
PubMed 19207712McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PubMed 17179269McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
PubMed 17961838El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
PubMed 19376789
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
- Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection- a Double Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01339273
- Acronym / sponsor ID
- Sponsorship review number:113
- Keywords
- TAP block, Laparoscopic hemicolectomy, Laparoscopic anterior resection, laparoscopic colonic resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery.
Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge.
The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)
Detailed description
Summary of Study Design The study will be a double blind randomised controlled trial with patients undergoing laparoscopic right hemicolectomy or laparoscopic high anterior resection randomly allocated into two groups, with the study group receiving bilateral TAP blocks followed by a morphine PCA and the control group receiving local anaesthetic infiltration of the laparoscopic port sites and specimen extraction site and a morphine PCA.
A double blind design was chosen to eliminate patient and observer bias in reporting of pain scores.
The presence of the control arm will ensure that any difference observed will be due to the effect of sensory nerve block due to the TAP block than due to the systemic effect of the injected local anaesthetic.
The null hypothesis will be that there is no difference between the groups in the amount of morphine consumed by the patients during 48 hours after the operation. We chose this measurement as an objective but indirect measurement of efficacy of TAP block and pain relief thus received. Measurement of pain with various scoring methods are reliable only when concurrent reduction in consumption of pain killers are demonstrated.
Recruitment and randomisation:
All patients meeting the inclusion criteria will receive a patient information leaflet and an invitation letter to participate in the study during the pre-assessment visit. We aim to recruit 72 patients (36 patients per group).
Informed consent will be taken by one of the investigators on the morning of the surgery, if the exclusion criteria are not applicable. Patients will be allotted consecutive participant numbers starting from one. Patients will be randomly allocated into either the study group and a control group. Randomisation will occur by using computer generated random numbers. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-6 anaesthetic room of Churchill hospital.Once patient has consented, the anaesthetist will open the corresponding numbered envelope and perform bilateral TAP blocks after induction of general anaesthesia, if the patient is in the study group the surgeons will infiltrate the port sites with local anaesthetic at the end of the procedure if the patient is in the control group.
Blinding:
The study group will receive bilateral TAP blocks with 20mls 0.25% bupivacaine on each side and the skin punctures on either sides will be covered with a small plaster. Patients in the control group will receive subcutaneous infiltration of the laparoscopic port sites and specimen extraction site with equivalent amount bupivacaine at the end of the procedure and small plasters will be stuck on either flanks approximately where the skin punctures for TAP block will be made.
The assessor of pain scores and morphine doses (Recovery nurse \& Colo-rectal house officer) and the patient will be blinded to group allocation.
Patient: Plasters will be stuck on flanks of all the patients both study and control group so that patient will not know if they have received TAP block.
Recovery nurse: During handover to recovery the anaesthetist and scrub nurse will not mention about group allocation.
Colo-rectal house officer: The house officers( Junior Doctors) who will be following up in the ward will not present in the operating theatre, so they will be blinded
The study duration will be from induction of anaesthesia until the patients are medically fit for discharge from hospital. No extra visits other than routinely required for the surgical procedure is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: Ultrasound guided Transversus Abdominis Plane (TAP) bockPatients in this arm will receive ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster |
| Local anaesthetic infiltration | Active comparator | Procedure: Local anaesthetic infiltration of laparoscopic port sitesLaparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Undergoing elective laparoscopic high anterior resection without stoma or laparoscopic right hemicolectomy.
- American Society of Anaesthetists physical status (ASA) 1-3
Key exclusion criteria (8 listed)
- Opioid tolerance
- Chronic abdominal pain
- Allergy/Intolerance: Morphine, local anaesthetics
- BMI>35 Kg/M2
- Previous major abdominal 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 |
|---|---|---|
| Ultrasound guided Transversus Abdominis Plane (TAP) bockUltrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster | Procedure or surgery | TAP block |
| Local anaesthetic infiltration of laparoscopic port sitesLaparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made. | Procedure or surgery | Local anaesthetic infiltration |
Primary outcome
Morphine Consumption in the First 48hours After the Operation
Time frame: 48 hours after the operation
Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.
13 secondary outcomes
Numerical Rating Pain Scores at 48 Hours Postoperatively
Time frame: 48 hours after the operation
Nausea Score at 48 Hours Postoperatively
Time frame: 48 hours after the operation
Time to First Request for Rescue Analgesia
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Mobilisation
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Successful Intake of Fluids
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Resumption of Normal Diet
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to First Bowel Motion
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to First Flatus
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Time to Medically Fit to Discharge
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.
Total Morphine Consumption at 24hours
Time frame: 24 hours
Nausea at 24hours Post Operatively
Time frame: 24 hours
Time to Mobilization
Time frame: days
Time to Hospital Discharge
Time frame: days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19207712Zafar N, Davies R, Greenslade GL, Dixon AR. The evolution of analgesia in an 'accelerated' recovery programme for resectional laparoscopic colorectal surgery with anastomosis. Colorectal Dis. 2010 Feb;12(2):119-24. doi: 10.1111/j.1463-1318.2009.01768.x. Epub 2009 Jan 16.
- Background: PubMed 17179269McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
- Background: PubMed 17961838McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
- Background: PubMed 19376789El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
Related trials for Colonic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Nicholas Crabtree, MB,ChB, FRCA principal investigator
Nuffield Department of Anaesthetics, Oxford Radcliffe Hospitals NHS Trust , Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Transversus Abdominis Plane (TAP) bock and Local anaesthetic infiltration of laparoscopic port sites in people with Colonic Cancer and Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 8 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 1 site in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morphine Consumption in the First 48hours After the Operation (time frame: 48 hours after the operation). 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 NCT01339273, which also lists 4 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.