PainTapBlockNCT05427266
Laparoscopic Transversus Abdominis Plane Block (LTAP) for Appendicectomy Versus Standard Port Site Treatment
A study testing Tap Block - Bupivacaine in people with Pain and Appendicitis, run by Royal College of Surgeons, Ireland.
Trial summary
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and 24 hours following laparoscopic appendicectomy Tap Block is a standard conventional analgesia protocol for laparoscopic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Appendicitis, Surgery
- What is being tested?
- Tap Block - Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for follow up telephone follow up
- Male or female, aged over 18
- Diagnosed either clinically or radiologically (CT/US/MRI) with appendicitis
- Uncomplicated or complicated appendicitis
- Undergoing laparoscopic appendicitis surgery only
- Must be fluent in English in order to complete telephone follow up questionnaire
- Fulfillment of each criteria must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.
Who cannot join
- Male or female under the age or 18
- Laparoscopic converted to open appendicectomy (during surgical procedure)
- Open appendicectomy (planned)
- Pregnancy.
- Females must not be breastfeeding
- Known allergic reactions to components of the study product(s) )
Show all 12Show fewer
- Not fluent in English - which would prevent participants to complete follow up telephone questionnaire
- Malignant appendicitis
- Spinal Anaesthesia, Epidural analgesia catheter or injections, Post-operative requirements for patient controlled analgesia (PCA)
- Right hemicolectomy or any concomitant or simultaneous intervention
- Allergy or hypersensitivity to any of the components of Bupivacaine
- Presence of any other illness or condition that renders the patient unsuitable for trial participation in the opinion of the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laparoscopic Transversus Abdominis Plane Block (LTAP) (Tap Block) for Appendicectomy Versus Standard Port Site Treatment
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and 24 hours following laparoscopic appendicectomy Tap Block is a standard conventional analgesia protocol for laparoscopic appendicitis used in Beaumont Hospital, and other hospitals throughout Ireland.
The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block
Read the detailed description
Title: Randomised Controlled Trial to compare Laparoscopic Transversus Abdominis Plane Block (LTAP) for appendicectomy versus standard treatment Short title: (TAP Block Study) Laparoscopic Transversus Abdominis Plane Block for Appendicectomy - Single-Blinded Randomised controlled study
Objectives: Primary objectives:
To compare LTAP to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3,6, 12 and 24 hours following laparoscopic appendicectomy
Secondary objectives:
Post-operative Opioid requirement Time to first mobilisation post-operatively Length of stay in hospital Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
Type of trial: Multi centre Single blinded randomised control trial. (Beaumont Hospital and 3 other Dublin Hospitals) Trial design and methods: Study design: randomised controlled Single blind study. Patients will be allocated to one of two parallel groups in a 1:1 fashion. Patients and data analysts will be blinded as to modalities and group allocations. Surgeons and anaesthetists will be made aware of group allocations post randomisation.
Study groups and techniques of anaesthesia:
Control Group: standard port site infiltration using 0.25% plain bupivacaine. The dose is calculated to 2.5mg/kg per body weight. After the appendicectomy is done, after removal of ports and deflating the abdomen, the total calculated dose volume will be infiltrated into the subcutaneous plane at the umbilicus and the other 2 ports sites .
Study group: LTAP block in four points: above and below the umbilicus in both right and left sides; dose calculation 2.5mg per body weight.
After the appendicectomy is done and just before withdrawing port and deflating the abdomen, the operating surgeon will advance a needle into the abdominal wall to the level of the preperitoneal space. Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle. The surgeon then infiltrates the local anaesthetic into the plane, and the right plane is confirmed by visualising a uniform protrusion downwards of the TA muscle fibres (Doyle's bulge). Seeing a preperitoneal or muscle blister laparoscopically indicates that the infiltration is deeper to this plane, and the needle should be withdrawn more superficially.
Trial duration per participant: 1 month (follow up calls 1 week and 1 month post discharge) Estimated total trial duration: It is estimated that the trial recruitment will take 1 year (based on appendicitis admission rates in both Beaumont Hospital and 3 other Dublin Hospitals). The trial will end once the final patient's follow-up is completed and assessed.
Planned trial sites: Multi-site - sites Beaumont Hospital and 3 other Dublin hospitals Total number of participants planned: 172 86 Control Group 86 Study Group - TAP Block
- Conditions
- Pain, Appendicitis, Surgery, Analgesia, Laparoscopic, Bupivacaine
- Being tested
- Tap Block - Bupivacaine
- Medical subject headings
- Pain, Appendicitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap Block - BupivacaineOther
The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block (LTap Block)
| Study group | Role | What they receive |
|---|---|---|
| Study Group - Tap Block | Other | Study Group: Study group: Laparoscopic Transversus Abdominis Plane in four points: above and below the umbilicus in both right and left sides; dose calculation 2.5mg per body weight.
After the appendicectomy is done and just before withdrawing port and deflating the abdomen, the operating surgeon will advance a needle into the abdominal wall to the level of the preperitoneal space. Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle. The surgeon then infiltrates the local anaesthetic into the plane, and the right plane is confirmed by visualising a uniform protrusion downwards of the TA muscle fibres (Doyle's bulge). Seeing a preperitoneal or muscle blister laparoscopically indicates that the infiltration is deeper to this plane, and the needle should be withdrawn more superficially. Receives: Other: Tap Block - Bupivacaine |
| Control Group - Standard port site infiltration | Other | Patients will be randomised after diagnosis either clinically or radiologically of appendicitis (both complicated and uncomplicated) Control Group _ standard port site infiltration using 0.25% plain bupivacaine. The dose is calculated to 2.5mg/per kg body weight. After the appendicectomy is done, after removal of ports and deflating the abdomen, the total calculated dose volume will be infiltrated into the subcutaneous plane at the umbilicus and the other 2 ports sites Receives: Other: Tap Block - Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score)
Assessing any change in pain score from a scale of 1 to 10 (1 being the worst pain and 10 no pain) using VAS score template
Measured: Assessing change in pain score post extubation at 3 hours, 6 hours, 12 hours and 24 hours.
Secondary outcomes (4)
Post-operative Opioid requirement
Review of opioid requirement (dosage and time delivered) post operatively in both arms to assess if there is a difference in requirement
Measured: Assess opioid requirement post operatively in the first 24 hours
Time to first mobilisation post-operatively
Assess any difference in time to mobilization post operatively in both arms
Measured: Assess time to mobility in the first 24 hours post operatively
Length of stay in hospital
Assess if there are any difference in hospital stay in both arms
Measured: Assess length of stay from admission to discharge
Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
Phone follow up with EQ5DL questionnaire by research nurse to assess quality of life and overall satisfaction in both arms. The EQ-5DL The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems.
Measured: 1 week (up to 7 days) and 1 month up to 30 days post discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi centre Single blinded randomised control trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnold Hill, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427266
- Sponsor's protocol ID
- 22/31
- Acronym
- TapBlock
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Paper will be published in surgical journals
Publications
Daly GR, Dowling GP, Hembrecht S, O'Grady S, Hegarty A, Roche T, Orsi G, Pierre A, Calpin GG, Neary C, Hehir CM, Hill GJ, O'Brien A, Duggan WP, Davey MG, Stephens IJB, Kennedy ND, Brennan O, Hayes C, Al Azzawi M, Balasubramanian I, McGuire A, Zaborowski AM, Reynolds IS, Loughlin P, Allen M, Power C, Butt A, Boland MR, McCawley N, Burke JP, Robb WB, Mastrosimone A, Arumugasamy M, Prins H, Beddy D, Kerin MJ, McNamara DA, Kearney D, Sorensen J, Curley GF, Abd El Wahab S, Hill ADK. Laparoscopic-assisted transversus abdominis plane block versus port-site infiltration in appendicectomy: multicentre randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf257. doi: 10.1093/bjs/znaf257.
PubMed 41511871
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transversus Abdominis Plane Block (LTAP) (Tap Block) for Appendicectomy Versus Standard Port Site Treatment
- ClinicalTrials.gov ID
- NCT05427266
- Acronym / sponsor ID
- TapBlock / 22/31
- Conditions
- Pain, Appendicitis, Surgery, Analgesia, Laparoscopic, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare Laparoscopic assisted LTAP (Transversus Abdominis Plane) to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3, 6, 12 and 24 hours following laparoscopic appendicectomy Tap Block is a standard conventional analgesia protocol for laparoscopic appendicitis used in Beaumont Hospital, and other hospitals throughout Ireland.
The medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block
Detailed description
Title: Randomised Controlled Trial to compare Laparoscopic Transversus Abdominis Plane Block (LTAP) for appendicectomy versus standard treatment Short title: (TAP Block Study) Laparoscopic Transversus Abdominis Plane Block for Appendicectomy - Single-Blinded Randomised controlled study
Objectives: Primary objectives:
To compare LTAP to standard port-site infiltration in terms of post-operative visual analogue scores (VAS) for pain at 3,6, 12 and 24 hours following laparoscopic appendicectomy
Secondary objectives:
Post-operative Opioid requirement Time to first mobilisation post-operatively Length of stay in hospital Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
Type of trial: Multi centre Single blinded randomised control trial. (Beaumont Hospital and 3 other Dublin Hospitals) Trial design and methods: Study design: randomised controlled Single blind study. Patients will be allocated to one of two parallel groups in a 1:1 fashion. Patients and data analysts will be blinded as to modalities and group allocations. Surgeons and anaesthetists will be made aware of group allocations post randomisation.
Study groups and techniques of anaesthesia:
Control Group: standard port site infiltration using 0.25% plain bupivacaine. The dose is calculated to 2.5mg/kg per body weight. After the appendicectomy is done, after removal of ports and deflating the abdomen, the total calculated dose volume will be infiltrated into the subcutaneous plane at the umbilicus and the other 2 ports sites .
Study group: LTAP block in four points: above and below the umbilicus in both right and left sides; dose calculation 2.5mg per body weight.
After the appendicectomy is done and just before withdrawing port and deflating the abdomen, the operating surgeon will advance a needle into the abdominal wall to the level of the preperitoneal space. Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle. The surgeon then infiltrates the local anaesthetic into the plane, and the right plane is confirmed by visualising a uniform protrusion downwards of the TA muscle fibres (Doyle's bulge). Seeing a preperitoneal or muscle blister laparoscopically indicates that the infiltration is deeper to this plane, and the needle should be withdrawn more superficially.
Trial duration per participant: 1 month (follow up calls 1 week and 1 month post discharge) Estimated total trial duration: It is estimated that the trial recruitment will take 1 year (based on appendicitis admission rates in both Beaumont Hospital and 3 other Dublin Hospitals). The trial will end once the final patient's follow-up is completed and assessed.
Planned trial sites: Multi-site - sites Beaumont Hospital and 3 other Dublin hospitals Total number of participants planned: 172 86 Control Group 86 Study Group - TAP Block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi centre Single blinded randomised control trial.
| Arm | Type | Receives |
|---|---|---|
| Study Group - Tap Block | Other | Other: Tap Block - BupivacaineStudy Group: Study group: Laparoscopic Transversus Abdominis Plane in four points: above and below the umbilicus in both right and left sides; dose calculation 2.5mg per body weight. After the appendicectomy is done and just before withdrawing port and deflating the abdomen, the operating surgeon will advance a needle into the abdominal wall to the level of the preperitoneal space. Once the needle tip is seen, it is withdrawn slowly and gently about 0.5cm above/superficial to the transversus abdominis (TA) muscle. The surgeon then infiltrates the local anaesthetic into the plane, and the right plane is confirmed by visualising a uniform protrusion downwards of the TA muscle fibres (Doyle's bulge). Seeing a preperitoneal or muscle blister laparoscopically indicates that the infiltration is deeper to this plane, and the needle should be withdrawn more superficially. |
| Control Group - Standard port site infiltration | Other | Other: Tap Block - BupivacainePatients will be randomised after diagnosis either clinically or radiologically of appendicitis (both complicated and uncomplicated) Control Group _ standard port site infiltration using 0.25% plain bupivacaine. The dose is calculated to 2.5mg/per kg body weight. After the appendicectomy is done, after removal of ports and deflating the abdomen, the total calculated dose volume will be infiltrated into the subcutaneous plane at the umbilicus and the other 2 ports sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for follow up telephone follow up
- Male or female, aged over 18
- Diagnosed either clinically or radiologically (CT/US/MRI) with appendicitis
- Uncomplicated or complicated appendicitis
Key exclusion criteria (12 listed)
- Male or female under the age or 18
- Laparoscopic converted to open appendicectomy (during surgical procedure)
- Open appendicectomy (planned)
- Pregnancy.
- Females must not be breastfeeding
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 Block - BupivacaineThe medicinal product for both groups is the same - Bupivacaine. The mode of administration is what this study is reviewing: Control group (Standard port site infiltration) and Study Group - Laparoscopic Transversus Abdominis Plane Block (LTap Block) | Other | Control Group - Standard port site infiltration, Study Group - Tap Block |
Primary outcome
Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score)
Time frame: Assessing change in pain score post extubation at 3 hours, 6 hours, 12 hours and 24 hours.
Assessing any change in pain score from a scale of 1 to 10 (1 being the worst pain and 10 no pain) using VAS score template
4 secondary outcomes
Post-operative Opioid requirement
Time frame: Assess opioid requirement post operatively in the first 24 hours
Time to first mobilisation post-operatively
Time frame: Assess time to mobility in the first 24 hours post operatively
Length of stay in hospital
Time frame: Assess length of stay from admission to discharge
Quality of Life Questionnaire (at 1 week and 1 month post discharge) (EQ5DL)
Time frame: 1 week (up to 7 days) and 1 month up to 30 days post discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 41511871Daly GR, Dowling GP, Hembrecht S, O'Grady S, Hegarty A, Roche T, Orsi G, Pierre A, Calpin GG, Neary C, Hehir CM, Hill GJ, O'Brien A, Duggan WP, Davey MG, Stephens IJB, Kennedy ND, Brennan O, Hayes C, Al Azzawi M, Balasubramanian I, McGuire A, Zaborowski AM, Reynolds IS, Loughlin P, Allen M, Power C, Butt A, Boland MR, McCawley N, Burke JP, Robb WB, Mastrosimone A, Arumugasamy M, Prins H, Beddy D, Kerin MJ, McNamara DA, Kearney D, Sorensen J, Curley GF, Abd El Wahab S, Hill ADK. Laparoscopic-assisted transversus abdominis plane block versus port-site infiltration in appendicectomy: multicentre randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf257. doi: 10.1093/bjs/znaf257.
- Individual participant dataSharing planned: Yes. Paper will be published in surgical journals
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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.
Arnold Hill principal investigator
Royal College of Surgeons in Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Tap Block - Bupivacaine in people with Pain and Appendicitis, run by Royal College of Surgeons, Ireland.
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 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sorcha O'Grady (0873156654, sorchaogrady@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing pain post laparoscopic appendicectomy using Visual analogue score (VAS score) (time frame: Assessing change in pain score post extubation at 3 hours, 6 hours, 12 hours and 24 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 NCT05427266, which also lists 1 linked publication.
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 Jun 2022.