Pain, Post OperativeNCT05348083
Erector Spinae Plane Block (ESPB) Versus Quadratus Lumborum Block (QLB) for Postoperative Analgesia After Caesarean Section
An observational study of Pain, Post Operative and Cesarean Section Complications, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Post Operative, Cesarean Section Complications, Anesthesia, Local
- What is being tested?
- ESPB
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2021to 30 Oct 2022
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study is an observational comparative study, including a prospective cohort (the ESPB group) and a historical control group (the p-QLB group) from our institution.
Who may be able to join
- Patients ASA 2 with normal singleton pregnancy, scheduled for elective caesarean section without intrathecal morphine, who underwent bilateral ESPB at the end of surgery an who gave informed consent to data collection.
Who cannot join
- Contraindications to spinal anesthesia;
- Contraindications to or a history of opioid dependence;
- Allergy to local anesthetics, acetaminophen, NSAIDs
- Inability to understand pain assessment scales or to use Patient Controlled Analgesia (PCA) pump;
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Erector Spinae Plane Block (ESPB) Versus Posterior Quadratus Lumborum Block (p-QLB) for Postoperative Analgesia After Caesarean Section: an Observational Closed Mixed Cohort Study
Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Recently, the need for alterative opioid sparing techniques is emerging. Paraspinal fascial plane blocks, as quadratus lumborum block (QLB) and erector spinae plane block (ESPB) performed at T9 level, have therefore been proposed as alternatives to ITM, because of their demonstrated effect on visceral and somatic pain.
The aim of the study is to assess the efficacy, the feasibility and safety of bilateral ESPB compared to bilateral QLB for the management of postoperative pain after ceasarean section conducted under spinal anesthesia without ITM.
- Conditions
- Pain, Post Operative, Cesarean Section Complications, Anesthesia, Local, Obstetric Anesthesia Problems
- Being tested
- ESPB
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBProcedure or surgery
Echo-guided bilateral ESPB performed at T9 level at the end of surgery with a mixture of ropivacaine 0.375% and epinephrine 5 mcg/mL 20 mL each side.
| Study group | Role | What they receive |
|---|---|---|
| ESPB | A prospective cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided ESPB at T9 level at the end of surgery. Receives: Procedure: ESPB | |
| p-QLB | A historical cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided p-QLB at the end of surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption at 24 h
Total morphine consumption at 24 hours from block performance
Measured: 24 hours from block performance
Secondary outcomes (8)
Intensity of pain at time of block performance
NRS (Numeric Rating Scale) for pain at rest and on movement at time of block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)
Measured: Time of block performance, at the end of surgery
Intensity of pain at 2 hours
NRS (Numeric Rating Scale) for pain at rest and on movement at 2 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)
Measured: 2 hours from block performance
Intensity of pain at 6 hours
NRS (Numeric Rating Scale) for pain at rest and on movement at 6 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)
Measured: 6 hours from block performance
Intensity of pain at 12 hours
NRS (Numeric Rating Scale) for pain at rest and on movement at 12 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)
Measured: 12 hours from block performance
Intensity of pain at 24 hours
NRS (Numeric Rating Scale) for pain at rest and on movement at 24 hours from block performance. NRS is an 11-point numeric scale ranging from 0 (= no pain) to 10 (=extreme pain)
Measured: 24 hours from block performance
Adverse events
Any adverse events, like sedation, itching, nausea, and other complications, particularly signs of local anesthetic toxicity, the occurrence or persistence of motor weakness at the lower extremities after spinal anesthesia recovery.
Measured: Any time during the first 24 hours from block performance.
Time to first opioid request
Interval time between block and first opioid analgesic request
Measured: Any time during the first 24 hours from block performance
Differences in hemodynamic parameters
Any difference in hemodynamic parameters (non-invasive blood pressure, heart rate)
Measured: Any time during the first 24 hours from block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start15 Dec 2021
- Primary completion20 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Post OperativeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZANFINI BRUNO ANTONIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348083
- Sponsor's protocol ID
- 4412
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2021
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Erector Spinae Plane Block (ESPB) Versus Posterior Quadratus Lumborum Block (p-QLB) for Postoperative Analgesia After Caesarean Section: an Observational Closed Mixed Cohort Study
- ClinicalTrials.gov ID
- NCT05348083
- Acronym / sponsor ID
- 4412
- Conditions
- Pain, Post Operative, Cesarean Section Complications, Anesthesia, Local, Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 27 Apr 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.
Management of pain after caesarean section represents an important anesthesiologic issue, since it is often suboptimal, leading to delayed functional recovery and chronic pain. Currently, the postoperative analgesic strategy mostly relies on intrathecal morphine (ITM) and multimodal analgesic regimen. Recently, the need for alterative opioid sparing techniques is emerging. Paraspinal fascial plane blocks, as quadratus lumborum block (QLB) and erector spinae plane block (ESPB) performed at T9 level, have therefore been proposed as alternatives to ITM, because of their demonstrated effect on visceral and somatic pain.
The aim of the study is to assess the efficacy, the feasibility and safety of bilateral ESPB compared to bilateral QLB for the management of postoperative pain after ceasarean section conducted under spinal anesthesia without ITM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | – | Procedure: ESPBA prospective cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided ESPB at T9 level at the end of surgery. |
| p-QLB | – | –A historical cohort of 25 patients ASA 2 (according to American Society of Anesthesiologists physical status classification) with normal singleton pregnancy, scheduled for elective caesarean section under spinal anesthesia without intrathecal morphine, who underwent bilateral echo-guided p-QLB at the end of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is an observational comparative study, including a prospective cohort (the ESPB group) and a historical control group (the p-QLB group) from our institution.
Key inclusion criteria (1 listed)
- Patients ASA 2 with normal singleton pregnancy, scheduled for elective caesarean section without intrathecal morphine, who underwent bilateral ESPB at the end of surgery an who gave informed consent to data collection.
Key exclusion criteria (5 listed)
- Contraindications to spinal anesthesia;
- Contraindications to or a history of opioid dependence;
- Allergy to local anesthetics, acetaminophen, NSAIDs
- Inability to understand pain assessment scales or to use Patient Controlled Analgesia (PCA) pump;
- Patient refusal.
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 |
|---|---|---|
| ESPBEcho-guided bilateral ESPB performed at T9 level at the end of surgery with a mixture of ropivacaine 0.375% and epinephrine 5 mcg/mL 20 mL each side. | Procedure or surgery | ESPB |
Primary outcome
Opioid consumption at 24 h
Time frame: 24 hours from block performance
Total morphine consumption at 24 hours from block performance
8 secondary outcomes
Intensity of pain at time of block performance
Time frame: Time of block performance, at the end of surgery
Intensity of pain at 2 hours
Time frame: 2 hours from block performance
Intensity of pain at 6 hours
Time frame: 6 hours from block performance
Intensity of pain at 12 hours
Time frame: 12 hours from block performance
Intensity of pain at 24 hours
Time frame: 24 hours from block performance
Adverse events
Time frame: Any time during the first 24 hours from block performance.
Time to first opioid request
Time frame: Any time during the first 24 hours from block performance
Differences in hemodynamic parameters
Time frame: Any time during the first 24 hours from block performance
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 17 Oct 2023.
- 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.
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?
An observational study of Pain, Post Operative and Cesarean Section Complications, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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 17 Oct 2023. 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 Italy. 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?
Opioid consumption at 24 h (time frame: 24 hours from block performance). 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 17 Oct 2023.