Acute AppendicitisNCT03252561
TAP Block for Laparoscopic Appendicectomy in Adults
A study testing Ultrasound guided Transversus Abdominis Plane (TAP) bock and Local anaesthetic infiltration of laparoscopic port sites in people with Acute Appendicitis, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Laparoscopic (key-hole) appendicectomy 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 16 years and older
- Conditions the study is for
- Acute Appendicitis
- 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
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants willing and able to give informed consent for participation in the study
- Male or Female, aged 16 years or above
- Undergoing laparoscopic appendicectomy for a clinical diagnosis of appendicitis
- American Society of Anaesthetists physical status (ASA) 1-3
Who cannot join
- Opioid tolerance
- Chronic abdominal pain
- Allergy/Intolerance: Morphine, local anaesthetics, tramadol
- BMI (Body Mass Index) >35 Kg/M2
- Previous major abdominal surgery
- High likelihood of conversion of open procedure
Show all 9Show fewer
- Patients unable to communicate in written and spoken English
- Weight less than 50 kg
- ASA > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Appendicectomy in Adults: A Double Blind Randomised Controlled Trial
Laparoscopic (key-hole) appendicectomy 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. Opioids are associated with an increased incidence of nausea, vomiting and sedation which can complicate post-operative recovery. Different techniques of intraoperative infiltration of local anaesthetic to control postoperative pain are also being used. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects.
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, a reduction in post-operative nausea and vomiting 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 the investigator's hospital.
Read the detailed description
Summary of Study Design: The study will be a double blind randomised controlled trial with patients undergoing laparoscopic appendicectomy randomly allocated into two groups. The study group will receive bilateral TAP blocks and the control group will receive local anaesthetic infiltration of the laparoscopic port sites
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 opioids consumed by the patients during 24 hours after the operation. The investigators 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 about the study during the procedure and investigators will gain informed consent during the procedure consultation. Investigators aim to recruit 288 patients with 144 patients in each group.
Informed consent will be taken the evening before, or on the morning of, surgery. Patients will then be randomly allocated into either the study group or a control group. Randomisation will occur by using computer generated random numbers using the block randomisation method. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-4/emergency theatre anaesthetic room of the John Radcliffe Hospital. Once the 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, Ward Nursing Staff \& SEU Foundation Doctor) 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 group allocation.
SEU Foundation Doctor: The foundation doctor who will be following up patients on the ward will not be present in the operating theatre, ensuring that they are blinded to the technique used.
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 are expected.
- Conditions
- Acute Appendicitis
- Being tested
- Ultrasound guided Transversus Abdominis Plane (TAP) bock, Local anaesthetic infiltration of laparoscopic port sites
- Keywords
- TAP block, Acute Appendicitis, Post-operative analgesia
- Medical subject headings
- Appendicitis
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 will be infiltrated with a total of 20 mls 0.5% 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 will be infiltrated with a total of 20 mls 0.5% 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.
Opioid consumption in the first 12 hours after the operation
The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.
Measured: 12 hours
Secondary outcomes (5)
Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively
Measured: 24 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 opioid was administered
Measured: 24 hours after the operation
Nausea score at emergence, 6, 12, 24 hours postoperatively
Measured: 24 hours after the operation
Total length of hospital stay
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 length of 1-5 days
Opioid consumption at 24 hours
Consumption of morphine or other opioids (including tramadol) in the first 24 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios
Measured: 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Study no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Silva, MBBS,MD,FRCS, Principal investigator, Consultant Upper G SurgeonNicholas Crabtree, MBChB,FRCA, Principal investigator, Consultant Anaesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252561
- Sponsor's protocol ID
- Sponsorship No. 249
- Status last verified
- Jun 2020
- First submitted
- 20 Apr 2015
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
PubMed 19561014Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
PubMed 21504934McDonnell 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 17961838
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 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 Appendicectomy in Adults: A Double Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03252561
- Acronym / sponsor ID
- Sponsorship No. 249
- Conditions
- Acute Appendicitis
- Keywords
- TAP block, Acute Appendicitis, Post-operative analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Aug 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.
Laparoscopic (key-hole) appendicectomy 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. Opioids are associated with an increased incidence of nausea, vomiting and sedation which can complicate post-operative recovery. Different techniques of intraoperative infiltration of local anaesthetic to control postoperative pain are also being used. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects.
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, a reduction in post-operative nausea and vomiting 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 the investigator's hospital.
Detailed description
Summary of Study Design: The study will be a double blind randomised controlled trial with patients undergoing laparoscopic appendicectomy randomly allocated into two groups. The study group will receive bilateral TAP blocks and the control group will receive local anaesthetic infiltration of the laparoscopic port sites
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 opioids consumed by the patients during 24 hours after the operation. The investigators 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 about the study during the procedure and investigators will gain informed consent during the procedure consultation. Investigators aim to recruit 288 patients with 144 patients in each group.
Informed consent will be taken the evening before, or on the morning of, surgery. Patients will then be randomly allocated into either the study group or a control group. Randomisation will occur by using computer generated random numbers using the block randomisation method. Group allocation will be kept in a consecutively numbered, opaque, sealed envelope in the controlled drugs cupboard in theatre-4/emergency theatre anaesthetic room of the John Radcliffe Hospital. Once the 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, Ward Nursing Staff \& SEU Foundation Doctor) 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 group allocation.
SEU Foundation Doctor: The foundation doctor who will be following up patients on the ward will not be present in the operating theatre, ensuring that they are blinded to the technique used.
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 are 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 will be infiltrated with a total of 20 mls 0.5% 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
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants willing and able to give informed consent for participation in the study
- Male or Female, aged 16 years or above
- Undergoing laparoscopic appendicectomy for a clinical diagnosis of appendicitis
- American Society of Anaesthetists physical status (ASA) 1-3
Key exclusion criteria (9 listed)
- Opioid tolerance
- Chronic abdominal pain
- Allergy/Intolerance: Morphine, local anaesthetics, tramadol
- BMI (Body Mass Index) >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 will be infiltrated with a total of 20 mls 0.5% 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
Opioid consumption in the first 12 hours after the operation
Time frame: 12 hours
The primary endpoint will be consumption of morphine or other opioids (including tramadol) in the first 12 hours after the operation. This will be recorded from the drug chart. Morphine equivalents include fentanyl, codeine and tramadol and will be converted into total morphine consumption using recognised conversion ratios.
5 secondary outcomes
Numerical rating pain scores at emergence, 6, 12, 24 hours postoperatively
Time frame: 24 hours after the operation
Time to first request for rescue analgesia
Time frame: 24 hours after the operation
Nausea score at emergence, 6, 12, 24 hours postoperatively
Time frame: 24 hours after the operation
Total length of hospital stay
Time frame: After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected length of 1-5 days
Opioid consumption at 24 hours
Time frame: 24 hours after the operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 19561014Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
- Background: PubMed 21504934Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
- 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.
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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.
Michael Silva, MBBS,MD,FRCS principal investigator
Consultant Upper G Surgeon
Nicholas Crabtree, MBChB,FRCA principal investigator
Consultant Anaesthetist
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 Acute Appendicitis, 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 9 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: withdrawn, as of the sponsor's last update on 16 Jun 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Opioid consumption in the first 12 hours after the operation (time frame: 12 hours). 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 NCT03252561, which also lists 3 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 16 Jun 2020.