Postoperative AnalgesiaNCT04689633
Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
A study testing nerve block in people with Postoperative Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2019to 15 Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia
Who cannot join
- Allergy to studed drugs
- morbid obesity
- patient refusal
- infection at the side of the bolck
- emergency laparoscopic cholecystectomy
- if laparoscopic procedure converted to open
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any block
Read the detailed description
on arrival to the operative room all patients were monitored with standared monitoring. then IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively.
- Conditions
- Postoperative Analgesia
- Being tested
- nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve blockProcedure or surgery
bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Active comparator | received bilateral ultrasound-guided Quadratus lumborum block using 20 ml bupivacaine 0.25% on each side Receives: Procedure: nerve block |
| Erector spinae block | Active comparator | received bilateral ultrasound-guided erector spinae block using 20 ml bupivacaine 0.25% on each side Receives: Procedure: nerve block |
| Control | No intervention | didn't received any block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of first postoperative analgesic request
first time that patient need analgesia and visual analogue scale more than 3
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 posted30 Dec 2020
- Study start15 Apr 2019
- Primary completion15 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadwa Rabea Mohamed, Minia University
- Investigators
- Abeer Hassaneen, MD, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689633
- Sponsor's protocol ID
- 135-12/2018
- Status last verified
- Dec 2018
- First submitted
- 29 Dec 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04689633
- Acronym / sponsor ID
- 135-12/2018
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 30 Dec 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 patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any block
Detailed description
on arrival to the operative room all patients were monitored with standared monitoring. then IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Active comparator | Procedure: nerve blockreceived bilateral ultrasound-guided Quadratus lumborum block using 20 ml bupivacaine 0.25% on each side |
| Erector spinae block | Active comparator | Procedure: nerve blockreceived bilateral ultrasound-guided erector spinae block using 20 ml bupivacaine 0.25% on each side |
| Control | No intervention | –didn't received any block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia
Key exclusion criteria (6 listed)
- Allergy to studed drugs
- morbid obesity
- patient refusal
- infection at the side of the bolck
- emergency laparoscopic cholecystectomy
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 |
|---|---|---|
| nerve blockbilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest | Procedure or surgery | Erector spinae block, Quadratus lumborum block |
Primary outcome
time of first postoperative analgesic request
Time frame: 24 hours
first time that patient need analgesia and visual analogue scale more than 3
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 4 Mar 2021.
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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.
Abeer Hassaneen, MD study chair
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block in people with Postoperative Analgesia, run by Minia 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 1 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 4 Mar 2021. 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?
time of first postoperative analgesic request (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 4 Mar 2021.