AnalgesiaNCT04965194
Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies
A study testing erector spinae plane block and Quadratus lumborum plane block in people with Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies. This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- erector spinae plane block and Quadratus lumborum plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 1 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Open laparotomies.
Who cannot join
- Patient refusal
- Allergy to local anesthetics
- BMI >40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric diseases.
- Infection of the skin at the site of needle punctures area.
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 Analgesia in Laparotomies: Randomized Controlled Study
The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.
This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study.
Read more
According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one).
Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.
Read the detailed description
Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.
Primary outcome:
Total analgesic consumption in the first 24hrs postoperative.
Secondary outcomes:
- Time of first analgesic request.
- Visual analogue pain score in the first 24hrs postoperative
- Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery.
In ES group: superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T7. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
In QL group: A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Before the end of the surgery all patients will receive 1g of paracetamol IV, at the end of the surgery reversal of neuromuscular blockade will be done by neostigmine and atropine and then the patients will be transferred to recovery room. 30 mg of ketorolac will be given to all patients every 8 hrs.
Parameters will be assessed:
Intraoperative:
Hemodynamics after induction of anesthesia, after block and then every 15min till the end of surgery.
Postoperative:
- Hemodynamics immediately after recovery and then 1, 2, 4, 8, 12, 16, 20and 24 hrs postoperative.
- VAS in the same previous intervals.
- Time of first analgesic request.
- Total analgesic requirement in the first 24 hrs. postoperative.
- Incidence of side effects.
- Conditions
- Analgesia
- Being tested
- erector spinae plane block, Quadratus lumborum plane block, placebo
- Keywords
- ESPB, QLPB, analgesia, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
Quadratus lumborum plane blockProcedure or surgery
A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
placeboOther
patients received no regional block
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block (ESPB) | Experimental | 20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side Receives: Procedure: erector spinae plane block |
| Quadratus lumborum plane block (QLPB) | Experimental | The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1. Receives: Procedure: Quadratus lumborum plane block |
| Control group | Placebo comparator | patients received no regional block Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic consumption
total fentanyl consumption as rescue analgesia
Measured: 24 hours
Secondary outcomes (3)
Time of first analgesic request.
first dose of rescue analgesia
Measured: 24 hours
dynamic Visual analogue pain score
degree of pain description on movement from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain
Measured: 24 hours
resting Visual analogue pain score
degree of pain description on rest from (0-10 )which 0-3 is the no pain, 4-5 mild pain, 6-8 moderate pain and 9-10 severe pain
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 posted16 Jul 2021
- Study start15 Jul 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- 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
- Shadwa R Mohamed, MD, Study chair, Mina university hospitalAhmed H Mohamed, Study director, Minia Universiry hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965194
- Sponsor's protocol ID
- 50:6/2021
- Status last verified
- Nov 2022
- First submitted
- 3 Jul 2021
- Last updated
- 4 Nov 2022
- Results posted
- 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 4 Nov 2022. 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 Analgesia in Laparotomies: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04965194
- Acronym / sponsor ID
- 50:6/2021
- Conditions
- Analgesia
- Keywords
- ESPB, QLPB, analgesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Jul 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.
The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.
This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study.
According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one).
Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.
Detailed description
Postoperative pain management is one of the most important issues influencing the outcome of surgery. Postoperative pain, especially when poorly controlled, results in harmful acute effects such as adverse physiological responses and chronic effects like delayed long term recovery and chronic pain.the investigators aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies.
Primary outcome:
Total analgesic consumption in the first 24hrs postoperative.
Secondary outcomes:
- Time of first analgesic request.
- Visual analogue pain score in the first 24hrs postoperative
- Incidence of any side effects. All patients will be premedicated using midazolam 0.03 mg /kg iv upon arrival to the operating room then standard monitoring which included SPO2, ECG, non-invasive blood pressure monitoring will be applied. All patients will receive the same anesthetic technique. Following anesthesia induction using 1-2 mcg/kg fentanyl, 2- 3 mg/kg propofol, and 0.5 mg/kg atracurium, the patients will be intubated and maintenance of anesthesia will be done by Isoflurane (MAC 1.2) and intermittent doses of atracurium to maintain adequate muscle relaxation. All hemodynamics will be measured before and after induction of general anesthesia and then every 5 min till end of surgery.
In ES group: superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T7. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
In QL group: A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Before the end of the surgery all patients will receive 1g of paracetamol IV, at the end of the surgery reversal of neuromuscular blockade will be done by neostigmine and atropine and then the patients will be transferred to recovery room. 30 mg of ketorolac will be given to all patients every 8 hrs.
Parameters will be assessed:
Intraoperative:
Hemodynamics after induction of anesthesia, after block and then every 15min till the end of surgery.
Postoperative:
- Hemodynamics immediately after recovery and then 1, 2, 4, 8, 12, 16, 20and 24 hrs postoperative.
- VAS in the same previous intervals.
- Time of first analgesic request.
- Total analgesic requirement in the first 24 hrs. postoperative.
- Incidence of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block (ESPB) | Experimental | Procedure: erector spinae plane block20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side |
| Quadratus lumborum plane block (QLPB) | Experimental | Procedure: Quadratus lumborum plane blockThe injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1. |
| Control group | Placebo comparator | Other: placebopatients received no regional block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Open laparotomies.
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to local anesthetics
- BMI >40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric 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 |
|---|---|---|
| erector spinae plane blockSuperficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen. | Procedure or surgery | Erector spinae plane block (ESPB) |
| Quadratus lumborum plane blockA curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1. | Procedure or surgery | Quadratus lumborum plane block (QLPB) |
| placebopatients received no regional block | Other | Control group |
Primary outcome
Total analgesic consumption
Time frame: 24 hours
total fentanyl consumption as rescue analgesia
3 secondary outcomes
Time of first analgesic request.
Time frame: 24 hours
dynamic Visual analogue pain score
Time frame: 24 hours
resting Visual analogue pain score
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 4 Nov 2022.
- 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.
Shadwa R Mohamed, MD study chair
Mina university hospital
Ahmed H Mohamed study director
Minia Universiry hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block and Quadratus lumborum plane block in people with 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 4 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 Nov 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. 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?
Total analgesic consumption (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 Nov 2022.