Breast CancerNCT05301595
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
A study testing TAP block and QL Block in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TAP block and QL Block
- 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 siteCanada
- Study dates
- Apr 2022to Mar 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction
- Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III
Who cannot join
- Patients not consenting for regional block
- Patients allergic to local anesthetics and adjuvants
- Patients with America Society of Anesthesiologists (ASA) physical status class IV and V
- Patients with any baseline opiate consumption
- Presence of infection at needle insertion site
- Patients with coagulopathy (INR>1.3)
- Patients with thrombocytopenia (Platelets<100)
- Patients on therapeutic anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.
Read the detailed description
Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap.
Postoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience.
A multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients.
Transversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure.
More recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia.
This study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction.
- Conditions
- Breast Cancer
- Being tested
- TAP block, QL Block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Please see description of TAP block group.
QL BlockProcedure or surgery
Please see description of QL block group.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia.
Patients in this group will have bilateral sham blocks performed after PV block is complete. 2ml of normal saline will be injected under the skin bilaterally near the insertion site of a typical QL block.
TAP block will be performed intraoperatively by the surgeon. The anesthesiologist will provide the surgeon with 40ml of LA mixture (ropivacaine 0.25%, epinephrine 100mcg and dexamethasone 4mg) for patients in this group. The surgeon will be blinded to the injectate content. The TAP block is performed once the abdominal flap has been harvested. The triangle of Petit is landmarked by the iliac crest inferiorly, the latissimus dorsi muscle posteriorly and the external oblique muscle anteriorly. A blunt tip needle is advanced through the external oblique fascia and internal oblique fascia. A total volume 20mL of the LA mixture will be injected per side. Receives: Procedure: TAP block |
| QL block | Active comparator | All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia.
Patients in this group will have QL block performed after PV block is complete. This will be performed with patients in the prone position using the transverse in-plane technique. With realtime U/S guidance, the quadratus lumborum muscle is identified before a short-bevel needle is advanced into the plane between the quadratus lumborum and psoas major muscles. Needle tip position is confirmed by separation of quadratus lumborum and psoas major upon injection. 20ml of ropivacaine 0.25%, epinephrine 50mcg and dexamethasone 2mg will be injected per side.
TAP block is performed intraoperatively similar to above but with 40mL of normal saline to perform a sham block. The anesthesiologist will provide the surgeon with 40ml of normal saline in this group. The surgeon will be blinded to the injectate content. Receives: Procedure: QL Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 survey
Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 1. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.
Measured: post-operative day #1
Secondary outcomes (9)
Quality of Recovery-15 survey
Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 2. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.
Measured: post-operative day #2
Quality of Recovery-15 survey
Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 3. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.
Measured: post-operative day #3
Pain visual analog scale
Pain visual analog scale (VAS) is a 1 to 10 continuous scale used to determine the intensity of a patient's pain at any given time. For any given time, the minimum value is 1 (no pain) and the maximum value is 10 (pain as bad as it could possibly be). The lower the number, the less intense the pain and better outcome.
Measured: 1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours
Time elapsed before first analgesic requirement
Time that has elapsed since surgery before first analgesic medication is needed.
Measured: post-operative day #0 to 3
Total analgesic drug requirements
The total amount of analgesic medication patient requires in the first 3 days after surgery
Measured: post-operative day #0 to 3
Total antiemetic drug requirements
The total amount of antiemetic medication patient requires in the first 3 days after surgery
Measured: post-operative day #0 to 3
Ambulation
Ability of patient to ambulate (e.g. up to chair, mobilizing with assistance, mobilizing independently) in the first 3 days after surgery.
Measured: post-operative day #0 to 3
Surgical complication
Any acute surgical complications experienced by the patient in the first three days after surgery.
Measured: post-operative day #0 to 3
Block complication
Any acute nerve-block related complications experienced by the patient in the first three days after surgery.
Measured: post-operative day #0 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Study was never started as PI moved to another city
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moein Momtazi, Ottawa Hospital Research Institute
- Investigators
- Moein Momtazi, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301595
- Sponsor's protocol ID
- 20210817-01H
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy
- ClinicalTrials.gov ID
- NCT05301595
- Acronym / sponsor ID
- 20210817-01H
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started as PI moved to another city
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 29 Mar 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.
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.
Detailed description
Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap.
Postoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience.
A multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients.
Transversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure.
More recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia.
This study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Procedure: TAP blockAll patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia. Patients in this group will have bilateral sham blocks performed after PV block is complete. 2ml of normal saline will be injected under the skin bilaterally near the insertion site of a typical QL block. TAP block will be performed intraoperatively by the surgeon. The anesthesiologist will provide the surgeon with 40ml of LA mixture (ropivacaine 0.25%, epinephrine 100mcg and dexamethasone 4mg) for patients in this group. The surgeon will be blinded to the injectate content. The TAP block is performed once the abdominal flap has been harvested. The triangle of Petit is landmarked by the iliac crest inferiorly, the latissimus dorsi muscle posteriorly and the external oblique muscle anteriorly. A blunt tip needle is advanced through the external oblique fascia and internal oblique fascia. A total volume 20mL of the LA mixture will be injected per side. |
| QL block | Active comparator | Procedure: QL BlockAll patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia. Patients in this group will have QL block performed after PV block is complete. This will be performed with patients in the prone position using the transverse in-plane technique. With realtime U/S guidance, the quadratus lumborum muscle is identified before a short-bevel needle is advanced into the plane between the quadratus lumborum and psoas major muscles. Needle tip position is confirmed by separation of quadratus lumborum and psoas major upon injection. 20ml of ropivacaine 0.25%, epinephrine 50mcg and dexamethasone 2mg will be injected per side. TAP block is performed intraoperatively similar to above but with 40mL of normal saline to perform a sham block. The anesthesiologist will provide the surgeon with 40ml of normal saline in this group. The surgeon will be blinded to the injectate content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction
- Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III
Key exclusion criteria (8 listed)
- Patients not consenting for regional block
- Patients allergic to local anesthetics and adjuvants
- Patients with America Society of Anesthesiologists (ASA) physical status class IV and V
- Patients with any baseline opiate consumption
- Presence of infection at needle insertion site
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 blockPlease see description of TAP block group. | Procedure or surgery | TAP block |
| QL BlockPlease see description of QL block group. | Procedure or surgery | QL block |
Primary outcome
Quality of Recovery-15 survey
Time frame: post-operative day #1
Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 1. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.
9 secondary outcomes
Quality of Recovery-15 survey
Time frame: post-operative day #2
Quality of Recovery-15 survey
Time frame: post-operative day #3
Pain visual analog scale
Time frame: 1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours
Time elapsed before first analgesic requirement
Time frame: post-operative day #0 to 3
Total analgesic drug requirements
Time frame: post-operative day #0 to 3
Total antiemetic drug requirements
Time frame: post-operative day #0 to 3
Ambulation
Time frame: post-operative day #0 to 3
Surgical complication
Time frame: post-operative day #0 to 3
Block complication
Time frame: post-operative day #0 to 3
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moein Momtazi, MD principal investigator
Ottawa Hospital Research Institute
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 and QL Block in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 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: withdrawn, as of the sponsor's last update on 7 Nov 2023. 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 Canada. 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?
Quality of Recovery-15 survey (time frame: post-operative day #1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.