Cesarean SectionNCT05254093
Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section
A study testing Quadratus lumborum block and erector spinae plane block in people with Cesarean Section and Postoperative Analgesia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Cesarean section is the one of the most common surgical procedures. Inadequate pain management is associated with increased morbidity, costs, and maternal dissatisfaction. Furthermore, effective postoperative pain management enables mothers to care for their newborn infants. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Postoperative Analgesia
- What is being tested?
- Quadratus lumborum block and erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 16 Jul 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full-term, singleton, pregnant women,
- aged 18-35 years,
- scheduled for elective cesarean delivery under spinal anesthesia
Who cannot join
- American Society of Anesthesiologists (ASA) physical class III or more
- multiple gestation.
- Patients with a history of allergy to any of the study drugs, ,
- coagulopathy,
- local infection,
- history of chronic pain or
Show all 9Show fewer
- regular opioid use;
- inability to comprehend the numeric pain scale (NRS);
- and requirement for conversion to general anesthesia after spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Single Shot Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section: A Randomized Controlled Douple Blinded Trial
Cesarean section is the one of the most common surgical procedures. Inadequate pain management is associated with increased morbidity, costs, and maternal dissatisfaction. Furthermore, effective postoperative pain management enables mothers to care for their newborn infants. Systemic and neuraxial opioids are the cornerstone of postoperative pain management; however, opioids are associated with significant side effect such as respiratory depression, urine retention, constipation, and itching. To reduce the postoperative opioids requirement and subsequently their side effects, multimodal regimen is advice including neuraxial anesthesia, neuraxial morphine, regular administration of non-opioids analgesia (non-steroidal anti-inflammatory drugs and acetaminophen) and planned use of opioid for breakthrough pain.
The addition of peripheral nerve blocks to the multimodal analgesic plan was found to reduced postoperative opioids requirement in non-obstetric procedures.
Read more
Quadratus lumborum (QLB) and erector spinae plane (ESPB) blocks are relatively new techniques for peripheral nerve block and showed promising results in managing pain after Cesarean delivery.
There are several types of QLB that had been described. Lateral (QLB1), posterior (QLB2), and anterior (QLB3) quadratus lumborum blocks been studied in cesarean delivery and were found to reduce opioids requirement when compared against placebo. Cadaver studies suggest that local anesthetic deposition at QLB1 diffuses mainly to the transversus abdominis muscle plane while, at QLB2, and at QLB3 spread may occur into the thoracic paravertebral space providing additional visceral pain control.
ESPB can provide both visceral and somatic analgesia due to anterior spread to the paravertebral space. ESPB was found to reduce postoperative opioids requirement in comparison to transversus abdominis plane block and intrathecal morphine.
To the best of our knowledge, there is no published data comparing the analgesic effect of QLB3 (anterior QL) and ESPB after elective cesarean delivery.
Read the detailed description
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and ranitidine 50 mg). Lactated Ringer's co-load will be rapidly infused at a rate of 15 mL.Kg-1 over 10 minutes.
Spinal anesthesia will be achieved by injecting 2.0 to 2.3 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace.
The spinal block will be performed in the sitting position using a 25G spinal needle through midline approach. The participant will be then positioned supine with left-lateral uterine tilt. Pinprick was used for evaluation of block success 5 minutes after intrathecal injection. Successful block was confirmed if sensory block level was at T4 at least.
After skin closure and the covering of the wound with a dressing, patients received intravenous paracetamol (1 g) and ketorolac (30 mg).
Spinal block height will be assessed at the end of surgery to ensure enough anesthesia at the site of block performance. If the site of needle entry was not anesthetized, a local infiltration with 2ml of 20% lidocaine will be injected prior to the block. Patients will be blinded to block allocation using the surgical drapes to occlude their view. The patient will be into the lateral position and the back will be prepared in an aseptic manner.
after the end of the procedure the patients will receive their assigned intervention The blocks will be performed by experienced operator who will be informed of the patient group after patient positioning. The patient and the assessor of the block will be blinded to the study group.
Postoperative care All patients will receive parenteral paracetamol 1 g/6hours and ketorolac 30 mg/8hours postoperatively. Pain assessments using numerical rate scale (NRS) will be performed at rest and during movement (knee flexion) at 0.5, 1, 2, 4, 6, 18, 24 h after leaving the operating room. If NRS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted. if other opioid given, the morphine equivalent dose will be calculated from the opioid conversion chart.
All scores will be assigned by each patient with the assistance of an anesthesiologist not responsible for the surgical intervention.
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting. Complications: nausea, vomiting, itching, urine retention, sedation Age, weight, height and body mass index, duration of pregnancy, parity and gravity
- Conditions
- Cesarean Section, Postoperative Analgesia
- Being tested
- Quadratus lumborum block, erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockOther
quadratus lumborum block, anterior approach using a curvilinear (5-8MHz) transducer. The transducer will be positioned transverse above the iliac crest at the posterior axillary line and slided posteriorly till the Shamrock sign is identified (the transvers process represent the stem and the attached erector spinae, QL and Psoas major muscles represent the three leaves). A 22 G, 100 mm needle will be advanced in-plane from lateral to medial through the QL muscle to reach the inter-fascial plane between the QL and psoas major muscles, posterior to the transversalis fascia. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected anterior to the QL muscle. The procedure will be repeated on the opposite side of the back
erector spinae plane blockOther
the block will be given at the level of the 9th thoracic transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T9) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected below the muscle. The procedure will be repeated on the opposite side of the back
| Study group | Role | What they receive |
|---|---|---|
| group A | No intervention | Not described |
| group B | Active comparator | Not described Receives: Other: Quadratus lumborum block |
| group C | Active comparator | Not described Receives: Other: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement
hours
Measured: 15 minutes after intervention till 24 hours after suregery
Secondary outcomes (5)
numeric pain scale
from 0-10
Measured: at 0.5, 1, 2, 4, 6, 18, 24 hours postoperative
postoperative morphine requirement
mg
Measured: 15 minutes after intervention till 24 hours after surgery
time to independent movement
hours
Measured: 15 minutes after intervention till 24 hours after surgery
obstetric quality-of-recovery score
grade the following 0-10: Moderate pain Severe pain Nausea or vomiting Feeling dizzy Shivering Have been comfortable Able to mobilise independently Can hold baby without assistance Can feed/nurse baby without assistance Can look after personal hygiene/toilet Feeling in control
Measured: 24 hours after surgery
opioid related complication
nausea, vomiting, itching, urine retention, sedation
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Mar 2022
- Primary completion15 Jul 2022
- Study completion16 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254093
- Sponsor's protocol ID
- MD-60-2021
- Status last verified
- Jul 2022
- First submitted
- 15 Feb 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available from the PI upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Single Shot Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section: A Randomized Controlled Douple Blinded Trial
- ClinicalTrials.gov ID
- NCT05254093
- Acronym / sponsor ID
- MD-60-2021
- Conditions
- Cesarean Section, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 16 Jul 2022 (actual)
- First posted
- 24 Feb 2022 (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.
Cesarean section is the one of the most common surgical procedures. Inadequate pain management is associated with increased morbidity, costs, and maternal dissatisfaction. Furthermore, effective postoperative pain management enables mothers to care for their newborn infants. Systemic and neuraxial opioids are the cornerstone of postoperative pain management; however, opioids are associated with significant side effect such as respiratory depression, urine retention, constipation, and itching. To reduce the postoperative opioids requirement and subsequently their side effects, multimodal regimen is advice including neuraxial anesthesia, neuraxial morphine, regular administration of non-opioids analgesia (non-steroidal anti-inflammatory drugs and acetaminophen) and planned use of opioid for breakthrough pain.
The addition of peripheral nerve blocks to the multimodal analgesic plan was found to reduced postoperative opioids requirement in non-obstetric procedures.
Quadratus lumborum (QLB) and erector spinae plane (ESPB) blocks are relatively new techniques for peripheral nerve block and showed promising results in managing pain after Cesarean delivery.
There are several types of QLB that had been described. Lateral (QLB1), posterior (QLB2), and anterior (QLB3) quadratus lumborum blocks been studied in cesarean delivery and were found to reduce opioids requirement when compared against placebo. Cadaver studies suggest that local anesthetic deposition at QLB1 diffuses mainly to the transversus abdominis muscle plane while, at QLB2, and at QLB3 spread may occur into the thoracic paravertebral space providing additional visceral pain control.
ESPB can provide both visceral and somatic analgesia due to anterior spread to the paravertebral space. ESPB was found to reduce postoperative opioids requirement in comparison to transversus abdominis plane block and intrathecal morphine.
To the best of our knowledge, there is no published data comparing the analgesic effect of QLB3 (anterior QL) and ESPB after elective cesarean delivery.
Detailed description
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg, and ranitidine 50 mg). Lactated Ringer's co-load will be rapidly infused at a rate of 15 mL.Kg-1 over 10 minutes.
Spinal anesthesia will be achieved by injecting 2.0 to 2.3 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace.
The spinal block will be performed in the sitting position using a 25G spinal needle through midline approach. The participant will be then positioned supine with left-lateral uterine tilt. Pinprick was used for evaluation of block success 5 minutes after intrathecal injection. Successful block was confirmed if sensory block level was at T4 at least.
After skin closure and the covering of the wound with a dressing, patients received intravenous paracetamol (1 g) and ketorolac (30 mg).
Spinal block height will be assessed at the end of surgery to ensure enough anesthesia at the site of block performance. If the site of needle entry was not anesthetized, a local infiltration with 2ml of 20% lidocaine will be injected prior to the block. Patients will be blinded to block allocation using the surgical drapes to occlude their view. The patient will be into the lateral position and the back will be prepared in an aseptic manner.
after the end of the procedure the patients will receive their assigned intervention The blocks will be performed by experienced operator who will be informed of the patient group after patient positioning. The patient and the assessor of the block will be blinded to the study group.
Postoperative care All patients will receive parenteral paracetamol 1 g/6hours and ketorolac 30 mg/8hours postoperatively. Pain assessments using numerical rate scale (NRS) will be performed at rest and during movement (knee flexion) at 0.5, 1, 2, 4, 6, 18, 24 h after leaving the operating room. If NRS score is > 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted. if other opioid given, the morphine equivalent dose will be calculated from the opioid conversion chart.
All scores will be assigned by each patient with the assistance of an anesthesiologist not responsible for the surgical intervention.
Intravenous ondansetron 4 mg will be given to treat nausea or vomiting. Complications: nausea, vomiting, itching, urine retention, sedation Age, weight, height and body mass index, duration of pregnancy, parity and gravity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | No intervention | – |
| group B | Active comparator | Other: Quadratus lumborum block |
| group C | Active comparator | Other: erector spinae plane block |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full-term, singleton, pregnant women,
- aged 18-35 years,
- scheduled for elective cesarean delivery under spinal anesthesia
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists (ASA) physical class III or more
- multiple gestation.
- Patients with a history of allergy to any of the study drugs, ,
- coagulopathy,
- local infection,
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 |
|---|---|---|
| Quadratus lumborum blockquadratus lumborum block, anterior approach using a curvilinear (5-8MHz) transducer. The transducer will be positioned transverse above the iliac crest at the posterior axillary line and slided posteriorly till the Shamrock sign is identified (the transvers process represent the stem and the attached erector spinae, QL and Psoas major muscles represent the three leaves). A 22 G, 100 mm needle will be advanced in-plane from lateral to medial through the QL muscle to reach the inter-fascial plane between the QL and psoas major muscles, posterior to the transversalis fascia. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected anterior to the QL muscle. The procedure will be repeated on the opposite side of the back | Other | group B |
| erector spinae plane blockthe block will be given at the level of the 9th thoracic transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T9) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected below the muscle. The procedure will be repeated on the opposite side of the back | Other | group C |
Primary outcome
Time to first analgesic requirement
Time frame: 15 minutes after intervention till 24 hours after suregery
hours
5 secondary outcomes
numeric pain scale
Time frame: at 0.5, 1, 2, 4, 6, 18, 24 hours postoperative
postoperative morphine requirement
Time frame: 15 minutes after intervention till 24 hours after surgery
time to independent movement
Time frame: 15 minutes after intervention till 24 hours after surgery
obstetric quality-of-recovery score
Time frame: 24 hours after surgery
opioid related complication
Time frame: 24 hours after surgery
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 Jul 2022.
- Individual participant dataSharing planned: No. data will be available from the PI upon reasonable request
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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 Quadratus lumborum block and erector spinae plane block in people with Cesarean Section and Postoperative Analgesia, run by Kasr El Aini Hospital 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 3 inclusion and 9 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 Jul 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 analgesic requirement (time frame: 15 minutes after intervention till 24 hours after suregery). 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 Jul 2022.