Postoperative PainNCT03532906
Feasibility Study on Pain Control After Laparoscopic Cholecystectomy
A study testing TAP Block in people with Postoperative Pain, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy). The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TAP Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 26 Apr 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients able/willing to give informed consent for participation in the study.
- Male or female aged 18-60 years old.
Who cannot join
- Patients having an open cholecystectomy (performed through the standard "rope" incision).
- Patients intended to have laparoscopic cholecystectomy as an inpatient (staying overnight after surgery).
- Patients initially scheduled to have day case surgery but eventually admitted to hospital due to surgical or anaesthetic concerns or social reasons.
- Patients with contraindications in having injection of the local anaesthetic used in the study (i.e. history of side-effects, allergy).
- Patients who cannot have one or more standard oral painkillers prescribed postoperatively.
- Patients with history of chronic pain who are already on long term painkillers.
- Patients unable/unwilling to give informed consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX25DW
About this study
Official title: Is it Feasible to Conduct a Randomised Controlled Trial (RCT) of the Transverse Abdominis Plane (TAP) Block Versus Anaesthetic Injections to the Wound Site for Patients Requiring Laparoscopic Cholecystectomy?
The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy).
The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy.
Read more
One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only.
In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself.
The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.
Read the detailed description
Pain control after laparoscopic cholecystectomy can be achieved with the injection of local anaesthetic into the abdominal wall (TAP block) or into the surgical wounds. There is no reported literature comparing the two techniques with regard to early discharge rate, consumption of oral painkillers and return to daily activities in the week following surgery. In an era where day case surgery has become reality, there is a pressing need for strategies to optimize patients' pathways. In this context the postoperative pain control is a key point.
To compare the two techniques in a randomized trial, a large number of participants would be needed. Therefore the investigators would conduct a pilot study first, to evaluate if further research in the form of a larger study is likely to demonstrate the benefits of the TAP block during laparoscopic cholecystectomy.
During the developing of the research proposal, advice and comments had been given by the local Research and Development Department and the public.
Recruitment
Clinicians will identify potential participants in the surgical outpatient clinic. All patients who fulfil the entry criteria will be invited to take part in the study.
Participants will be fully informed verbally about the proposed study and will receive a Letter of invitation to participant and a Patient information leaflet to take home. That will give them adequate time to read the documents and make an informed choice.
Sample size
As being a feasibility study it is required to have 30 cases per group in the final dataset, with a total of 60 patients.
Consent
Patients will be informed about the study and receive the information leaflet at the time they are enrolled for an elective laparoscopic cholecystectomy in the surgical outpatient clinic. Only once patients are fully informed will they be asked to make a decision to enter the trial. Participants willing to join the study will have written informed consent, on the day of surgery.
Patients will be informed that they do not have to take part in the study if they choose to not be enrolled. Refusal to enter the trial will not compromise their care. Patients will also be informed that if at any time during the study they wish to withdraw they can do so, without having to give a reason and again this will not compromise their care. General Pratictioners will be informed by letter of their patients' inclusion in the study.
Risks and Benefits
There are no additional risks over and above participants' normal clinical care.
Both anaesthetic techniques are currently in use in the Royal Devon and Exeter National Heath System Foundation Trust. The procedures themselves do have potential risks (side-effects) which would be explained routinely to both trial and non-trial patients ahead of surgery. Taking part in this study will not change these risks in any way.
There are no immediate benefits to the participants from taking part in the trial at present. However, if the results are promising, the investigators will run a larger trial that could potentially lead to a new way of looking after patients having laparoscopic cholecystectomy.
That may therefore lead to a future change in medical care that could help patients who will be having laparoscopic cholecystectomy.
The investigators would be clear that no new technique or medication is being tested. Also there is no financial benefit from the study to both the participants and the research team.
Conflicts of Interest
None.
Confidentiality
All data will be stored anonymously against a participant number. Only the clinical team and research nurse will have access to the single table correlating participant's name number. Anonymity will be preserved throughout the trial.
- Conditions
- Postoperative Pain
- Being tested
- TAP Block, Control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockDrug
Also called Bupivacaine 0.5%
Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds.
ControlDrug
Also called Bupivacaine 0.5%
Injection of Bupivacaine 0.5% 10 ml into the surgical wounds
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | Patients receive the injection of local anaesthetic into the right abdominal wall (TAP block) together with the injection of local anaesthetic into the surgical wounds. Receives: Drug: TAP Block |
| Control | Other | Patients receive the injection of local anaesthetic into the surgical wounds only. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount number of patients who give their consent to take part to the study
Overall ability to recruit participants
Measured: 24 months
Total number of questionnaire responses
Ability to follow-up participants
Measured: 24 months
Total number of number of patients adhering to follow-up
Ability to collect adequate data
Measured: 24 months
Secondary outcomes (3)
Standard deviation (SD) of hospital stay between the two study arms
To understand if the intervention significantly impacts the length of hospital stay
Measured: 24 months
Standard deviation (SD) of questionnaire scores between the two study arms
To understand if the intervention significantly impacts the scores on the follow-up questionnaire
Measured: 24 months
Standard deviation (SD) of costs (hospital stay and prescription of painkillers) between the two study arms
To understand if the intervention significantly yields a financial benefit
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Jul 2018
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Manzelli, MD, PhD, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532906
- Sponsor's protocol ID
- 1901750
- Status last verified
- Mar 2021
- First submitted
- 27 Apr 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a feasibility study therefore sharing of individual participant data is not considered for further studies.
Publications
Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
PubMed 11576144Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.
PubMed 26397443Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
PubMed 21154380Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
PubMed 21296242De Oliveira GS Jr, Castro-Alves LJ, Nader A, Kendall MC, McCarthy RJ. Transversus abdominis plane block to ameliorate postoperative pain outcomes after laparoscopic surgery: a meta-analysis of randomized controlled trials. Anesth Analg. 2014 Feb;118(2):454-463. doi: 10.1213/ANE.0000000000000066.
PubMed 24445643Pourseidi B, Khorram-Manesh A. Effect of intercostals neural blockade with Marcaine (bupivacaine) on postoperative pain after laparoscopic cholecystectomy. Surg Endosc. 2007 Sep;21(9):1557-9. doi: 10.1007/s00464-006-9181-9. Epub 2007 Mar 7.
PubMed 17342558El-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 19376789Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.
PubMed 26787793
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Feasible to Conduct a Randomised Controlled Trial (RCT) of the Transverse Abdominis Plane (TAP) Block Versus Anaesthetic Injections to the Wound Site for Patients Requiring Laparoscopic Cholecystectomy?
- ClinicalTrials.gov ID
- NCT03532906
- Acronym / sponsor ID
- 1901750
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 22 May 2018 (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 objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy).
The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy.
One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only.
In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself.
The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.
Detailed description
Pain control after laparoscopic cholecystectomy can be achieved with the injection of local anaesthetic into the abdominal wall (TAP block) or into the surgical wounds. There is no reported literature comparing the two techniques with regard to early discharge rate, consumption of oral painkillers and return to daily activities in the week following surgery. In an era where day case surgery has become reality, there is a pressing need for strategies to optimize patients' pathways. In this context the postoperative pain control is a key point.
To compare the two techniques in a randomized trial, a large number of participants would be needed. Therefore the investigators would conduct a pilot study first, to evaluate if further research in the form of a larger study is likely to demonstrate the benefits of the TAP block during laparoscopic cholecystectomy.
During the developing of the research proposal, advice and comments had been given by the local Research and Development Department and the public.
Recruitment
Clinicians will identify potential participants in the surgical outpatient clinic. All patients who fulfil the entry criteria will be invited to take part in the study.
Participants will be fully informed verbally about the proposed study and will receive a Letter of invitation to participant and a Patient information leaflet to take home. That will give them adequate time to read the documents and make an informed choice.
Sample size
As being a feasibility study it is required to have 30 cases per group in the final dataset, with a total of 60 patients.
Consent
Patients will be informed about the study and receive the information leaflet at the time they are enrolled for an elective laparoscopic cholecystectomy in the surgical outpatient clinic. Only once patients are fully informed will they be asked to make a decision to enter the trial. Participants willing to join the study will have written informed consent, on the day of surgery.
Patients will be informed that they do not have to take part in the study if they choose to not be enrolled. Refusal to enter the trial will not compromise their care. Patients will also be informed that if at any time during the study they wish to withdraw they can do so, without having to give a reason and again this will not compromise their care. General Pratictioners will be informed by letter of their patients' inclusion in the study.
Risks and Benefits
There are no additional risks over and above participants' normal clinical care.
Both anaesthetic techniques are currently in use in the Royal Devon and Exeter National Heath System Foundation Trust. The procedures themselves do have potential risks (side-effects) which would be explained routinely to both trial and non-trial patients ahead of surgery. Taking part in this study will not change these risks in any way.
There are no immediate benefits to the participants from taking part in the trial at present. However, if the results are promising, the investigators will run a larger trial that could potentially lead to a new way of looking after patients having laparoscopic cholecystectomy.
That may therefore lead to a future change in medical care that could help patients who will be having laparoscopic cholecystectomy.
The investigators would be clear that no new technique or medication is being tested. Also there is no financial benefit from the study to both the participants and the research team.
Conflicts of Interest
None.
Confidentiality
All data will be stored anonymously against a participant number. Only the clinical team and research nurse will have access to the single table correlating participant's name number. Anonymity will be preserved throughout the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Drug: TAP BlockPatients receive the injection of local anaesthetic into the right abdominal wall (TAP block) together with the injection of local anaesthetic into the surgical wounds. |
| Control | Other | Drug: ControlPatients receive the injection of local anaesthetic into the surgical wounds only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients able/willing to give informed consent for participation in the study.
- Male or female aged 18-60 years old.
Key exclusion criteria (7 listed)
- Patients having an open cholecystectomy (performed through the standard "rope" incision).
- Patients intended to have laparoscopic cholecystectomy as an inpatient (staying overnight after surgery).
- Patients initially scheduled to have day case surgery but eventually admitted to hospital due to surgical or anaesthetic concerns or social reasons.
- Patients with contraindications in having injection of the local anaesthetic used in the study (i.e. history of side-effects, allergy).
- Patients who cannot have one or more standard oral painkillers prescribed postoperatively.
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 |
|---|---|---|
| TAP BlockAlso: Bupivacaine 0.5%Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds. | Drug | TAP block |
| ControlAlso: Bupivacaine 0.5%Injection of Bupivacaine 0.5% 10 ml into the surgical wounds | Drug | Control |
Primary outcome
Total amount number of patients who give their consent to take part to the study
Time frame: 24 months
Overall ability to recruit participants
Total number of questionnaire responses
Time frame: 24 months
Ability to follow-up participants
Total number of number of patients adhering to follow-up
Time frame: 24 months
Ability to collect adequate data
3 secondary outcomes
Standard deviation (SD) of hospital stay between the two study arms
Time frame: 24 months
Standard deviation (SD) of questionnaire scores between the two study arms
Time frame: 24 months
Standard deviation (SD) of costs (hospital stay and prescription of painkillers) between the two study arms
Time frame: 24 months
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 28 Apr 2021.
- Results publication: PubMed 11576144Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
- Results publication: PubMed 26397443Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.
- Results publication: PubMed 21154380Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
- Results publication: PubMed 21296242Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Results publication: PubMed 24445643De Oliveira GS Jr, Castro-Alves LJ, Nader A, Kendall MC, McCarthy RJ. Transversus abdominis plane block to ameliorate postoperative pain outcomes after laparoscopic surgery: a meta-analysis of randomized controlled trials. Anesth Analg. 2014 Feb;118(2):454-463. doi: 10.1213/ANE.0000000000000066.
- Results publication: PubMed 17342558Pourseidi B, Khorram-Manesh A. Effect of intercostals neural blockade with Marcaine (bupivacaine) on postoperative pain after laparoscopic cholecystectomy. Surg Endosc. 2007 Sep;21(9):1557-9. doi: 10.1007/s00464-006-9181-9. Epub 2007 Mar 7.
- Results publication: 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.
- Results publication: PubMed 26787793Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.
- Individual participant dataSharing planned: No. It is a feasibility study therefore sharing of individual participant data is not considered for further studies.
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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.
Antonio Manzelli, MD, PhD principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block in people with Postoperative Pain, run by Royal Devon and Exeter NHS Foundation 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 2 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 28 Apr 2021. 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?
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?
Total amount number of patients who give their consent to take part to the study (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT03532906, which also lists 8 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 28 Apr 2021.