AnesthesiaNCT03490357
Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study
A study testing Quadratus Lumborum Block in people with Anesthesia, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 12 Jul 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
- • Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon
- Part of the ERAS protocol as listed by the surgeon
- Age 18 years and older
- Elective procedure
Who cannot join
- • Patient inability to consent
- Patient inability to communicate for data collection
- Conversion from laparoscopic to open case
- Local anesthetic allergy
- Weight less than 50 kg
- Anatomical variation making block visualization unlikely
Show all 11Show fewer
- Inability to cooperate with block
- Surgery posted longer than 6 hours
- Known preoperative substance abuse
- Chronic opioid use > 3 months
- Patient exhibits dependence on opioids Daily opioid use for pain control
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway
The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.
Read the detailed description
The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.
- Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.
- Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.
- Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis
- The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.
- The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the TAP block.
- Conditions
- Anesthesia
- Being tested
- Control - Transversus Abdominus Plane Block, Quadratus Lumborum Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - Transversus Abdominus Plane BlockProcedure or surgery
Abdominal fascial plane block - regional anesthesia
Quadratus Lumborum BlockProcedure or surgery
Abdominal fascial plane block - regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control - Transversus Abdominus Plane Block | Active comparator | Standardized ERAS regional nerve block Receives: Procedure: Control - Transversus Abdominus Plane Block |
| Quadratus Lumborum Block | Experimental | Quadratus lumborum nerve block Receives: Procedure: Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatomal Mapping
The primary outcome of interest is the proportion of subjects reporting a positive block. This is determined by dermatomal mapping in cephalad direction in PACU within 6 hours of TAP or QL placement. A positive outcome is one where the QL block measures 2 or more dermatomal levels higher than the TAP block
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start15 May 2018
- Primary completion11 Jul 2023
- Study completion12 Jul 2023
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 AnesthesiaStudies 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
- The expected cephalad dermatomal distribution of the TAP block is T10. A positive outcome is a QL block with patient anesthesia at 2 or more dermatomes higher than the TAP block. The investigators will assume that there is a 30% difference between the two blocks, which leads to between 24 and 33 patients in each arm (ideally aiming for 30 patients in each group). The investigators have included other sample sizes should they find that there is a higher or lower percentage difference between the QL and TAP blocks. Outcome: A positive block is considered anesthesia at T8 or above and a negative block is considered analgesia below T8
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renuka M George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490357
- Sponsor's protocol ID
- Pro00075597
- Status last verified
- Aug 2023
- First submitted
- 30 Mar 2018
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George RM, McSwain JR, Gukasov M, Wilson DA, Nitchie H, Wilson SH. Dermatomal spread in lateral quadratus lumborum blocks versus transversus abdominus plane blocks after laparoscopic colorectal surgery: a randomized clinical trial. Reg Anesth Pain Med. 2026 Feb 5;51(2):181-186. doi: 10.1136/rapm-2024-105488.
PubMed 39510803
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway
- ClinicalTrials.gov ID
- NCT03490357
- Acronym / sponsor ID
- Pro00075597
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 6 Apr 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 Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.
Detailed description
The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.
- Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.
- Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.
- Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis
- The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.
- The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the 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
- The expected cephalad dermatomal distribution of the TAP block is T10. A positive outcome is a QL block with patient anesthesia at 2 or more dermatomes higher than the TAP block. The investigators will assume that there is a 30% difference between the two blocks, which leads to between 24 and 33 patients in each arm (ideally aiming for 30 patients in each group). The investigators have included other sample sizes should they find that there is a higher or lower percentage difference between the QL and TAP blocks. Outcome: A positive block is considered anesthesia at T8 or above and a negative block is considered analgesia below T8
| Arm | Type | Receives |
|---|---|---|
| Control - Transversus Abdominus Plane Block | Active comparator | Procedure: Control - Transversus Abdominus Plane BlockStandardized ERAS regional nerve block |
| Quadratus Lumborum Block | Experimental | Procedure: Quadratus Lumborum BlockQuadratus lumborum nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon
Key exclusion criteria (11 listed)
- • Patient inability to consent
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 |
|---|---|---|
| Control - Transversus Abdominus Plane BlockAbdominal fascial plane block - regional anesthesia | Procedure or surgery | Control - Transversus Abdominus Plane Block |
| Quadratus Lumborum BlockAbdominal fascial plane block - regional anesthesia | Procedure or surgery | Quadratus Lumborum Block |
Primary outcome
Dermatomal Mapping
Time frame: 6 hours
The primary outcome of interest is the proportion of subjects reporting a positive block. This is determined by dermatomal mapping in cephalad direction in PACU within 6 hours of TAP or QL placement. A positive outcome is one where the QL block measures 2 or more dermatomal levels higher than the TAP block
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 8 Aug 2023.
- Derived from this study: PubMed 39510803George RM, McSwain JR, Gukasov M, Wilson DA, Nitchie H, Wilson SH. Dermatomal spread in lateral quadratus lumborum blocks versus transversus abdominus plane blocks after laparoscopic colorectal surgery: a randomized clinical trial. Reg Anesth Pain Med. 2026 Feb 5;51(2):181-186. doi: 10.1136/rapm-2024-105488.
- 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.
Renuka M George, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block in people with Anesthesia, run by Medical University of South Carolina at 1 site in United States.
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 11 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 8 Aug 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 United States. 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?
Dermatomal Mapping (time frame: 6 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 NCT03490357, 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 8 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.