Post Operative PainNCT05141955
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing Group Erector Spinae Plane Block (ESPB) and Group Quadratus Lumborum Block (QLB) in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postoperative pain control is a significant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Group Erector Spinae Plane Block (ESPB) and Group Quadratus Lumborum Block (QLB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Jun 2022
- 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
- Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
- BMI > 35 kg/ m2
Who cannot join
- Patients unfit for surgery or refuse to sign the consent of regional block.
- Patients with known coagulation defects.
- Patients with known hypersensitivity to bupivacaine.
- Patients with infection at the site of injection.
- Conversion of laparoscopic surgery to laparotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block
Postoperative pain control is a significant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.
The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.
The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.
- Conditions
- Post Operative Pain
- Being tested
- Group Erector Spinae Plane Block (ESPB), Group Quadratus Lumborum Block (QLB), Group (C) (Control group)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Erector Spinae Plane Block (ESPB)Other
Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg "
Group Quadratus Lumborum Block (QLB)Other
Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg "
Group (C) (Control group)Other
Where patients will be operated under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group Erector Spinae Plane Block (ESPB) | Active comparator | Not described Receives: Other: Group Erector Spinae Plane Block (ESPB) |
| Group Quadratus Lumborum Block (QLB) | Active comparator | Not described Receives: Other: Group Quadratus Lumborum Block (QLB) |
| Group (C) (Control group) | Other | Not described Receives: Other: Group (C) (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first requested rescue analgesia(Minutes)
Time to first requested rescue analgesia(Minutes)
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 posted2 Dec 2021
- Study start15 Dec 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141955
- Sponsor's protocol ID
- FMASU MS 705/ 2021
- Status last verified
- Jun 2022
- First submitted
- 30 Nov 2021
- Last updated
- 28 Jun 2022
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block
- ClinicalTrials.gov ID
- NCT05141955
- Acronym / sponsor ID
- FMASU MS 705/ 2021
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 2 Dec 2021 (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.
Postoperative pain control is a significant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.
The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.
The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Erector Spinae Plane Block (ESPB) | Active comparator | Other: Group Erector Spinae Plane Block (ESPB) |
| Group Quadratus Lumborum Block (QLB) | Active comparator | Other: Group Quadratus Lumborum Block (QLB) |
| Group (C) (Control group) | Other | Other: Group (C) (Control group) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
- BMI > 35 kg/ m2
Key exclusion criteria (5 listed)
- Patients unfit for surgery or refuse to sign the consent of regional block.
- Patients with known coagulation defects.
- Patients with known hypersensitivity to bupivacaine.
- Patients with infection at the site of injection.
- Conversion of laparoscopic surgery to laparotomy
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 |
|---|---|---|
| Group Erector Spinae Plane Block (ESPB)Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg " | Other | Group Erector Spinae Plane Block (ESPB) |
| Group Quadratus Lumborum Block (QLB)Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg " | Other | Group Quadratus Lumborum Block (QLB) |
| Group (C) (Control group)Where patients will be operated under general anesthesia. | Other | Group (C) (Control group) |
Primary outcome
Time to first requested rescue analgesia(Minutes)
Time frame: 24 hours postoperatively
Time to first requested rescue analgesia(Minutes)
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 28 Jun 2022.
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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 Group Erector Spinae Plane Block (ESPB) and Group Quadratus Lumborum Block (QLB) in people with Post Operative Pain, 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 2 inclusion and 5 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 28 Jun 2022. 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 to first requested rescue analgesia(Minutes) (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 28 Jun 2022.