Pain, PostoperativeNCT06655298
Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain ReliefFollowing Laparoscopic Nephrectomy
A study testing US guided block in people with Pain, Postoperative, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- US guided block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2023to 21 Oct 2024
- 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
- ASA I, II, III scheduled for laparoscopic nepheroctomy
Who cannot join
- patient refusal bleeding disorders neurological and psychological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain Relief After Laparoscopic Nephrectomy
The aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy.
Read the detailed description
The study will be a prospective randomized single-blind study. Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
The study will be conducted on 56 patients, 28 patients in each group:
Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) .
✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)
Data Collection:
Baseline:
- Patient demographic data
- Hemodynamics (pulse- heart rate- mean blood pressure), baseline before induction of anesthesia.
Intraoperative:
- Hemodynamics (pulse- heart rate- mean blood pressure): They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery.
- Total analgesic consumption needed to reach target Entropy measurement 40-60%.
- The anesthetic time (it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation) and surgical time (starts with skin incision and ends with last suture and putting dressings on).
- The time taken to perform the block.
- Number of patients needed ephedrine and/or atropine and total amount of their administration will be recorded.
- Recovery time (time since anesthetics discontinuation till reaching score 9 of Alderete's criteria).
Postoperative:
- Time of first call for rescue analgesia.
- Number of patients requested analgesia postoperative.
- Visual analogue scale (VAS) on admission to post-anesthetic care unit (PACU), every 30 minutes for next 2 hours, every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively.
- Discharge from PACU will be according to Postanesthesia Discharge Scoring System[14](Appendix3).
- Hemodynamics (pulse- heart rate- mean blood pressure) They will be assessed as follow:
- On admission to post-anesthetic care unit (PACU) then every 30 minutes at 30, 60, 90, 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours.
- Vomiting, nausea and starting time of intestinal movements.
- Duration of the block (from the injection time of local anesthetic till complete return of sensation).
- Conditions
- Pain, Postoperative
- Being tested
- US guided block
- Keywords
- erector spinae block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided blockDevice
Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) [9].
✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| group Q | Experimental | Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) Receives: Device: US guided block |
| group E | Experimental | Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) Receives: Device: US guided block |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia
determine the time of first call for rescue analgesia
Measured: 1 year
Secondary outcomes (1)
time
time taken to perform technique
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start21 Sep 2023
- Primary completion21 Nov 2023
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Hamza Sedky, Menoufia University
- Investigators
- Asmaa mohamed H Sedky, Study director, lectuerer of anathesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655298
- Sponsor's protocol ID
- 6/2023ANET44
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain Relief After Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT06655298
- Acronym / sponsor ID
- 6/2023ANET44
- Conditions
- Pain, Postoperative
- Keywords
- erector spinae block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 23 Oct 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 aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy.
Detailed description
The study will be a prospective randomized single-blind study. Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
The study will be conducted on 56 patients, 28 patients in each group:
Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) .
✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)
Data Collection:
Baseline:
- Patient demographic data
- Hemodynamics (pulse- heart rate- mean blood pressure), baseline before induction of anesthesia.
Intraoperative:
- Hemodynamics (pulse- heart rate- mean blood pressure): They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery.
- Total analgesic consumption needed to reach target Entropy measurement 40-60%.
- The anesthetic time (it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation) and surgical time (starts with skin incision and ends with last suture and putting dressings on).
- The time taken to perform the block.
- Number of patients needed ephedrine and/or atropine and total amount of their administration will be recorded.
- Recovery time (time since anesthetics discontinuation till reaching score 9 of Alderete's criteria).
Postoperative:
- Time of first call for rescue analgesia.
- Number of patients requested analgesia postoperative.
- Visual analogue scale (VAS) on admission to post-anesthetic care unit (PACU), every 30 minutes for next 2 hours, every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively.
- Discharge from PACU will be according to Postanesthesia Discharge Scoring System[14](Appendix3).
- Hemodynamics (pulse- heart rate- mean blood pressure) They will be assessed as follow:
- On admission to post-anesthetic care unit (PACU) then every 30 minutes at 30, 60, 90, 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours.
- Vomiting, nausea and starting time of intestinal movements.
- Duration of the block (from the injection time of local anesthetic till complete return of sensation).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block
| Arm | Type | Receives |
|---|---|---|
| group Q | Experimental | Device: US guided blockGroup Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) |
| group E | Experimental | Device: US guided blockGroup E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I, II, III scheduled for laparoscopic nepheroctomy
Key exclusion criteria (1 listed)
- patient refusal bleeding disorders neurological and psychological diseases
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 blockGroup Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) [9]. ✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg | Device | group E, group Q |
Primary outcome
analgesia
Time frame: 1 year
determine the time of first call for rescue analgesia
1 secondary outcome
time
Time frame: 1 year
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 26 Oct 2024.
- 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.
Asmaa mohamed H Sedky study director
lectuerer of anathesia
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 block in people with Pain, Postoperative, run by Menoufia 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 1 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 26 Oct 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?
analgesia (time frame: 1 year). 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 26 Oct 2024.