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Painless LaborNCT06393192

The Post Cesarean Section Analgesic Effect of Various Quadratus Lumborum Block Approaches

An observational study of Painless Labor and Epidural Analgesia, run by Sohag University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

included patients were divided into 4 groups and each group received a mode of post cesarian section analgesia and pain was assessed by visual analogue scale at rest and movement. 1. st group epidural analgesia 2. nd group Quadratus lumborum type 2 3. rd group Quadratus lumborum type 3 4. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
What is being tested?
Epidural analgesia (EA) only group, Quadratus lumborum block (QL2) and Quadratus lumborum block 3(QL3)
How many people
80 participants
Where
2 sitesEgypt
Study dates
1 Oct 2023to 15 Apr 2024
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: The current study is a prospective cohort study that was conducted on (80) patients in Sohag university hospital who were fulfilling the eligibility criteria and presented to the department of Obstetrics and Gynecology at Sohag University hospital (Egyptian tertiary referral hospital) who are requesting immediate postpartum analgesia. The attending physician had explained the nature of the study and all patients included signed an informed consent. All participants were subjected to thorough history taking including age, obstetric history, menstrual history, residency, occupation, medical history, surgical history and family history. Clinical examination and full investigations were done as preparation for elective cesarean section.

Who may be able to join

  • a normal singleton pregnancy lasting at least 37 weeks, body weight (50-70) kg, as well as having an American Society of Anesthesiologists (ASA) physical status I or II

Who cannot join

  • Individuals with a history of congenital coagulopathy, certain infections, or cognitive impairments that would prevent them from using the verbal rating pain score method or the patient-controlled analgesia (PCA) pump were not involved in the study

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Sohag University, Medical school

    Sohag, 82524

  • Sohag University hospital

    Sohag

Other trials in Egypt

About this study

Official title: Postoperative Analgesic Effects of Various Quadratus Lumborum Block Approaches Following Cesarean Section.

included patients were divided into 4 groups and each group received a mode of post cesarian section analgesia and pain was assessed by visual analogue scale at rest and movement.

  1. st group epidural analgesia
  2. nd group Quadratus lumborum type 2
  3. rd group Quadratus lumborum type 3
  4. th group Quadratus lumborum type (2+3)
Read the detailed description

Patients fulfilling the eligibility criteria were approached prior to delivery. The attending physician explained the nature of the study and all patients signed an informed consent then patients were divided in to four groups as follows (equal sample size in each group): the QLB type 2 (QL2 group), QLB type 3 (QL3 group), QLB type 2 +3 (QL2+3 group) and EA only group.

A 16-gauge intravenous cannula pathway was established in the non-dominant hand or arm in the operation unit. All parturient with standard monitoring including electrocardiogram, pulse arterial oxygen saturation, respiratory rate and non-invasive blood pressure (NIBP) was performed combined with spinal and epidural anesthesia before C-section in the left lateral position and peripheral nerve block at the end of surgery by an experienced doctor (A.M.A). The epidural needle was inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

After finding the epidural space using loss of resistance to saline technique, the tip of a spinal needle passed through the epidural needle. To achieve a sensory block height to the level of the sixth thoracic dermatome, every parturient received intrathecal anesthesia of 0.75% bupivacaine (1.3-1.7 )mL. Then, the needle was withdrawn and then an epidural catheter was inserted through the epidural needle in case the failure of intrathecal anesthesia. All surgical treatments were performed successfully in the usual manner.

Immediately after surgery, all subjects were transferred to the post-anesthesia care unit (PACU) and administered pre-determined analgesia, All parturient were lift in the supine position, tilting 45 degrees to the opposed side in order to place the low-frequency convex probe properly and see the sonography clearly. Bilateral QLB was performed using the atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks) advanced in-plane under the guidance of an ultrasound machine. The ultrasonogram of the abdominal wall was displayed clearly through probe moving or tilting. Pillows helped to relieve the tension along the abdominal wall of parturient. The whole procedure was performed strictly according to clinical protocol.

In this study, QL2 or QL3 were conducted through an anterolateral approach with the supine position as mentioned in (Sato et al, 2017). The ultrasound transducer was placed transversely on both flanks at the horizontal level of L2-3 and adjusted until the "Shamrock sign" formed of QL muscle, psoas major and erector spinae was visualized, with imaging depth set between 0 and 9.9 cm. Needles will be penetrated in an anterolateral to posteromedial direction. Local anesthetic will be injected posterior to QL muscle in QL2, while in QL3, it will be located between QL muscle and psoas major. QL2+3 block was conducted in the same plane with only one puncture on each side.

QL2 and QL3 groups received 0.2% ropivacaine at 30 mL at the sites mentioned above in each side for a total of 60 mL. For QL2+3 group, they recieved 0.2% ropivacaine 15 mL at each point of injection with the needle inserting only once in each side. The solution was injected after negative aspiration to exclude vascular puncture. As for the EA group, we used a single bolus of 6 mL saline solution containing 9 mg ropivacaine (0.15%) and 2 mg morphine via the epidural catheter as postoperative analgesia, and meanwhile, they received a procedure like QL2, but only saline was injected as placebo.

Epidural catheters were detached from all parturient after the procedure mentioned above. Parturient received a standard postoperative analgesic regime of regular oral paracetamol 1.0 g 6 hourly.

Being tested
Epidural analgesia (EA) only group, Quadratus lumborum block (QL2), Quadratus lumborum block 3(QL3), Quadratus lumborum block 2+3 QL(2+3)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural analgesia (EA) only groupProcedure or surgery

    The epidural needle will be inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

  • Quadratus lumborum block (QL2)Procedure or surgery

    0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side behind the QL muscle, resulting in a total of Sixty mL

  • Quadratus lumborum block 3(QL3)Procedure or surgery

    0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side among the QL muscle and the psoas major, resulting in a total of Sixty mL

  • Quadratus lumborum block 2+3 QL(2+3)Procedure or surgery

    0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Study groups in NCT06393192
Study groupRoleWhat they receive
Epidural analgesia (EA) only groupIn this group 20 patients fulfilling the eligibility criteria, the epidural needle was inserted at the level of the intervertebral gap that separates the 2nd \& 3rd spinal bones. Upon locating the epidural space through the utilization of the loss of resistance to saline approach, the tip of a spinal needle was inserted through the epidural needle. In order to reach a specific level of sensory block up to the sixth thoracic dermatome, each pregnant woman was administered intrathecal anesthetic consisting of 0.75 percent bupivacaine in a volume of 1.3-1.7 milliliter. Subsequently, we removed the needle \& proceeded to place an epidural catheter through the epidural needle as a precautionary measure in the event of intrathecal anesthetic failure. The EA group received a single dosage of six milliliters of saline solution containing nine milligrams of bupivacaine (0.15%) \& 2 mg of morphine via the epidural catheter for postoperative pain management.
Receives: Procedure: Epidural analgesia (EA) only group
Quadratus Lumborum 2 (QL2) groupIn this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered behind the QL muscle.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL
Receives: Procedure: Quadratus lumborum block (QL2)
Quadratus Lumborum 3 (QL3) groupIn this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered among the QL and the psoas major muscles.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL
Receives: Procedure: Quadratus lumborum block 3(QL3)
Quadratus Lumborum 2+3 (QL2+3) groupIn this group 20 patients fulfilling the eligibility criteria, the QL2+3 block can be performed in a single plane with only one puncture on each side. 0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side
Receives: Procedure: Quadratus lumborum block 2+3 QL(2+3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total morphine consumption

    Total morphine consumption at specified intervals following operation in addition to postoperative pain assessment by the visual analogue scale (VAS, 0-100 mm) at rest and movement

    Measured: zero, four, six, twelve, twenty-four hours & forty-eight hours postoperatively

Secondary outcomes (1)
  1. The side effects of the different interventions

    Nausea \& vomiting as well as itching, weak legs, urine retention, infection \& bleeding

    Measured: four, six, twelve, twenty-four hours & forty-eight hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start1 Oct 2023
  3. Primary completion28 Mar 2024
  4. Study completion15 Apr 2024

Resources

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
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393192
Sponsor's protocol ID
Soh-Med-23-09-6PD
Status last verified
Apr 2024
First submitted
27 Apr 2024
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data is available with authors and can be only shared after reasonable request and approval for Sohag medical research committee

Questions about this trial

What is this clinical trial studying?

An observational study of Painless Labor and Epidural Analgesia, run by Sohag University at 2 sites 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Total morphine consumption (time frame: zero, four, six, twelve, twenty-four hours & forty-eight 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 1 May 2024.

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