PainNCT04294329
Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery
A study testing US-guided Quadratus lumborum block., Bupivacaine and Saline in people with Pain and Postoperative, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- US-guided Quadratus lumborum block., Bupivacaine and Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2017to 31 Mar 2020
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients included in this study are
- Both genders
- Age between 18-50 years
- Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
- BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.
Who cannot join
- Patients excluded from this study were
- those with obstructive sleep apnoea and/or Pickwickian syndrome.
- if the laparoscopy procedure was converted to laparotomy.
- patients suffering from known coagulation defects.
- known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
- Presence of sepsis at the site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Anesthesiology department, Faculty of Medicine, Ain Shams University
Cairo
About this study
Official title: Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.
The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.
- Conditions
- Pain, Postoperative
- Being tested
- US-guided Quadratus lumborum block., Bupivacaine, Saline
- Keywords
- Quadratus lumborum block, laparoscopic bariatric surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided Quadratus lumborum block.Procedure or surgery
Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery
BupivacaineDrug
Bupivacaine
SalineDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group Quadratus lumborum block with bupivacaine | Experimental | After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose. Receives: Procedure: US-guided Quadratus lumborum block.; Drug: Bupivacaine |
| Group Quadratus lumborum block with saline | Placebo comparator | After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side. Receives: Procedure: US-guided Quadratus lumborum block.; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain severity
Assessment of analgesia intraoperatively and for the first 24 hours postoperatively using the numerical ratingscale (NRS)score .The scale ranges from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Intraoperative hemodynamics
Mean arterial pressure (MAP) in mmHg.
Measured: 24 hours postoperatively
Postoperative analgesic needs
Time to first analgesic requirement in hours
Measured: 24 hours postoperatively.
Total dose of opioids
Total dose of opioids received in mg
Measured: 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start15 Aug 2017
- Primary completion15 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Nofal, Ain Shams University
- Investigators
- Ahmed S. Omran, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams UniversityDoaa M. Kamal El-Din, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams UniveWalid H. Nofal, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams Unive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294329
- Sponsor's protocol ID
- FMASU R 18/2017
- Status last verified
- Aug 2020
- First submitted
- 14 Feb 2020
- Last updated
- 25 Aug 2020
- 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 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.
- ClinicalTrials.gov ID
- NCT04294329
- Acronym / sponsor ID
- FMASU R 18/2017
- Conditions
- Pain, Postoperative
- Keywords
- Quadratus lumborum block, laparoscopic bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Mar 2020 (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 was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Quadratus lumborum block with bupivacaine | Experimental | Procedure: US-guided Quadratus lumborum block., Drug: BupivacaineAfter induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose. |
| Group Quadratus lumborum block with saline | Placebo comparator | Procedure: US-guided Quadratus lumborum block., Drug: SalineAfter induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients included in this study are
- Both genders
- Age between 18-50 years
- Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
- BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.
Key exclusion criteria (6 listed)
- Patients excluded from this study were
- those with obstructive sleep apnoea and/or Pickwickian syndrome.
- if the laparoscopy procedure was converted to laparotomy.
- patients suffering from known coagulation defects.
- known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
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 |
|---|---|---|
| US-guided Quadratus lumborum block.Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery | Procedure or surgery | Group Quadratus lumborum block with bupivacaine, Group Quadratus lumborum block with saline |
| BupivacaineBupivacaine | Drug | Group Quadratus lumborum block with bupivacaine |
| Salinenormal saline | Drug | Group Quadratus lumborum block with saline |
Primary outcome
Postoperative pain severity
Time frame: 24 hours postoperatively
Assessment of analgesia intraoperatively and for the first 24 hours postoperatively using the numerical ratingscale (NRS)score .The scale ranges from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain imaginable.
3 secondary outcomes
Intraoperative hemodynamics
Time frame: 24 hours postoperatively
Postoperative analgesic needs
Time frame: 24 hours postoperatively.
Total dose of opioids
Time frame: 24 hours postoperatively.
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 25 Aug 2020.
- 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.
Ahmed S. Omran, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams University
Doaa M. Kamal El-Din, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams Unive
Walid H. Nofal, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams Unive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided Quadratus lumborum block., Bupivacaine and Saline in people with Pain and Postoperative, run by Ain Shams University 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 5 inclusion and 6 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 25 Aug 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 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. Some participants in this study may receive a placebo. 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?
Postoperative pain severity (time frame: 24 hours postoperatively). 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 25 Aug 2020.