Quadratus LumborumNCT06721039
Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block Versus Intraperitoneal and Periportal Bupivacaine Infiltration in Postoperative Analgesia After Laparoscopic Cholecystectomy
A study testing Bilateral QL block and Intraperitoneal and port sites infiltration in people with Quadratus Lumborum and Laparoscopic Cholecystectomy, run by medina medical center at 1 site in Egypt.
Trial summary
The primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Quadratus Lumborum, Laparoscopic Cholecystectomy, Ultrasound Guided
- What is being tested?
- Bilateral QL block and Intraperitoneal and port sites infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2022to 8 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-60 years of both sexes.
- Elective laparoscopic cholecystectomy under general anesthesia.
- Physical Status: ASA I and II patients after taking written and informed consent.
Who cannot join
- • Refusal of procedure or participation in the study by patients.
- Physical status: ASA III or above.
- Infection at site of injection.
- Psychiatric illness that leads to inability to cooperate, speak or read.
- Daily use of opioids.
- History or evidence of coagulopathy especially if INR>1.5 and platelet <100.000
- Allergies to drugs used (Bupivacaine 0.5%).
Trial locations and contacts
1 site in 1 country.
About this study
The primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Read the detailed description
Since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. The proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications.
The most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.
Intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. This technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. But as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. The choice of anaesthetic block technique depends upon the site of surgical incision proposed.
Quadratus lumborum (QL) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia.
This interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (Kadam, 2013).
- Conditions
- Quadratus Lumborum, Laparoscopic Cholecystectomy, Ultrasound Guided, Post Operative Analgesia
- Being tested
- Bilateral QL block, Intraperitoneal and port sites infiltration
- Keywords
- Quadratus Lumborum Plane Block, Intraperitoneal and Periportal Bupivacaine Infiltration, Post Operative Analgesia, Laparoscopic Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral QL blockDrug
sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes
Intraperitoneal and port sites infiltrationDrug
with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Bilateral QL block: sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes Receives: Drug: Bilateral QL block |
| Group 2 | Active comparator | Intraperitoneal and port sites infiltration with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes Receives: Drug: Intraperitoneal and port sites infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score postoperative
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start3 Apr 2022
- Primary completion3 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus LumborumStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- medina medical center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Salah Elsawy, medina medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721039
- Sponsor's protocol ID
- MS 168/2022
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block Versus Intraperitoneal and Periportal Bupivacaine Infiltration in Postoperative Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06721039
- Acronym / sponsor ID
- MS 168/2022
- Conditions
- Quadratus Lumborum, Laparoscopic Cholecystectomy, Ultrasound Guided, Post Operative Analgesia
- Keywords
- Quadratus Lumborum Plane Block, Intraperitoneal and Periportal Bupivacaine Infiltration, Post Operative Analgesia, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- medina medical centerUniversity, hospital or other
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 6 Dec 2024 (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 primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Detailed description
Since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. The proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications.
The most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.
Intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. This technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. But as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. The choice of anaesthetic block technique depends upon the site of surgical incision proposed.
Quadratus lumborum (QL) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia.
This interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (Kadam, 2013).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Bilateral QL blockBilateral QL block: sonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes |
| Group 2 | Active comparator | Drug: Intraperitoneal and port sites infiltrationIntraperitoneal and port sites infiltration with 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21-60 years of both sexes.
- Elective laparoscopic cholecystectomy under general anesthesia.
- Physical Status: ASA I and II patients after taking written and informed consent.
Key exclusion criteria (7 listed)
- • Refusal of procedure or participation in the study by patients.
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 |
|---|---|---|
| Bilateral QL blocksonovisible block needle will be inserted under ultra-sonographic monitoring between the iliac wing and rib at the midaxillary line for the TQL block in the lateral decubitus positioning of the patient. The space between the quadratus lumborum and psoas major muscles will be visualized with Ultrasound Guided and 0.25% bupivacaine will be injected after visualization of the tip of the needle reaching the plane, 2ml of anaesthetic solution will be instilled to view the hydro dissection, confirming the correct placement. Following this, the total volume of 40 ml of 0.25% bupivacaine will be instilled, creating a meniscus between the planes | Drug | Group 1 |
| Intraperitoneal and port sites infiltrationwith 40 ml of 0.25% bupivacaine will be injected under the direct vision into the hepato-diaphragmatic space, near and above the hepato-duodenal ligament and above the gall bladder also injected at the port sites at the end of operation before removal of the probes | Drug | Group 2 |
Primary outcome
pain score postoperative
Time frame: 24 hours
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 6 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral QL block and Intraperitoneal and port sites infiltration in people with Quadratus Lumborum and Laparoscopic Cholecystectomy, run by medina medical center at 1 site in Egypt.
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 3 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 6 Dec 2024. 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 Egypt. 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?
pain score postoperative (time frame: 24 hours). 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 6 Dec 2024.