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AnalgesiaNCT05617482

Comparison Between Ultrasound-guided Ilioinguinal, Iliohypogastric Nerve Blocks, TAP Block and Quadratus Lumborum Block in Patients Scheduled for Lower Segment Ceserian Sections.

A study testing General anesthesia, Ilioinguinal, iliohypogastric nerve blocks and TAP block in people with Analgesia, run by Tanta University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare between Ultrasound guided ilioinguinal, iliohypogastric nerve blocks, TAP block and Quadratus lumborum block in patients scheduled for lower segment ceserian sections. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Analgesia
What is being tested?
General anesthesia, Ilioinguinal, iliohypogastric nerve blocks and TAP block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 1 Mar 2023
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologists physical status 1 and 2
  • Aged between 18 and 45 years
  • Scheduled for emergency or elective lower segment cesarean section

Who cannot join

  • Pregnant women who will refuse to participate.
  • Known allergy to local anesthetic.
  • Infection at the block site.

About this study

Official title: Comparison Between Ultrasound-guided Ilioinguinal, Iliohypogastric Nerve Blocks, TAP Block and Quadratus Lumborum Block in Patients Scheduled for Lower Segment Ceserian Sections. A Randomized Controlled Trial

To compare between Ultrasound guided ilioinguinal, iliohypogastric nerve blocks, TAP block and Quadratus lumborum block in patients scheduled for lower segment ceserian sections.

Read the detailed description

One hundred and fifty patients belonging to the American Society of Anesthesiologists physical status 1 and 2, aged between 18 and 45 years and will be scheduled for emergency or elective lower segment cesarean section (LSCS) under general anesthesia will be selected between (December 2022 to March 2023, written informed consent will be obtained from all participants.

Inclusion criteria: ASA 1\& 2, Age between 18 and 45 years , scheduled for emergency or elective CS under spinal anesthesia; While exclusion criteria:pregnant women who will refuse to participate, known allergy to local anesthetic, infection at the block site.

Patients who will not willing to give consent, known allergy to local anesthetic or infection at the block site will be excluded from the study.

All patients will receive standard premedication according to institute protocol with ranitidine and metoclopramide intravenously immediately before shifting the patient into the operating room for emergency LSCS or 2 h before by oral route in case of elective LSCS. Inside the operating room under all aseptic precautions, spinal anesthesia will be administered using 1.8 ml of 0.5% of heavy bupivacaine without any adjuvant in L3-L4 space using Quincke's needle by the attending anesthesiologist. The case will be managed by the same person without any narcotics intraoperatively. At the end of the procedure just before the skin closure, 1 g of injection paracetamol will be administered intravenously over a period of 20 min as a part of multimodal analgesia. At the end of the surgery, patients will be randomized into ILIH (50 patients) , TAP block group (35 patients) or quadratus lumborum group (50 patients) by choosing a closed envelope, which will contain a standard data collection sheet and an allocation card. All the blocks were performed by the principle investigator under aseptic precautions and ultrasound guidance using high frequency linear probe resonating at 12 MHz in the multi-beam mode. In TAP block group, the probe will be placed perpendicular to the mid-axillary line between the iliac crest and the subcostal margin and the three abdominal muscle layers will be identified, and the transverses abdominis plane will be located between the internal oblique and the transverse abdominis muscle. The TAP will be approached through in-plane technique using a 23-gauge Quincke spinal needle attached to a 20 ml syringe of 0.25% bupivacaine will be injected and the drug spread in the plane will be observed. The same procedure will be repeated on the other side of the abdomen.

In ILIH group, the probe will be placed medial to the lateral one-third of the line joining the umbilicus and the anterior superior iliac spine (ASIS), with part of the probe sitting on the ASIS. The ASIS, iliacus muscle, internal oblique, transverses abdominis, and the ILIH nerves between them will be identified. After appreciating the sonoanatomy, the ILIH nerve will be approached with the 23-gauge Quincke spinal needle through in-plane technique and 10 ml of 0.25% bupivacaine will be injected all around and the drug spread will be appreciated. The same procedure will be repeated on the other side.

For the QLB, the transducer will be placed at the level of the anterosuperior iliac spine and will move cranially until the 3 abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border was visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the quadratus lumborum muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the middle layer of he thoracolumbar fascia. The needle (21 gauge) will be inserted in plane from anterolateral to posteromedial. The optimal point of injection for the QL block will be determined over the lumbar interfacial triangle using hydrodissection.

At the end of the procedure, patients will be shifted to the postanesthesia recovery room and later to the postoperative ward after establishing the block.

The sensory assessment following the TAP, ILIH, and QLB block will be done after confirming the spinal regression below the level of L2 dermatome. The block will be considered "Successful" when the patient will not be able to perceive the cold sensation at L1 dermatome (inguinal region) on both sides. The block will be considered "Partial" when patient perceives cold sensation on any one of the side.

The block will be considered "Failure" when the patient perceives cold sensation on both sides at L1 dermatome. Patients suffering partial and failed block will be excluded from the study for further analysis but will receive standard postoperative analgesics as any other patients. In the postoperative ward, whenever, the patient complained of pain, nurse in-charge will note the numerical rating scale (NRS) score, and will administered a single dose of injection diclofenac sodium of 50 mg as slow intravenous infusion over a period of 15 min and will note the time as time of first analgesia. Subsequently, whenever patient complain of pain, injection tramadol 50 mg will be given intravenously for the remaining 24 h.

A blinded observer who will not be aware of the group allocation will visit the patient at 2, 4, 6, 10, 12, and 24 h postoperative intervals and analyz the study parameters and record in the common standard data nalogue scale for pain (ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale) during rest as well as on movement (turning lateral to any one side). Duration of analgesia will be taken as time interval between the block time and the time of first analgesia.

The 24 h requirement of rescue analgesics injection diclofenac sodium and injection tramadol and complications such as nausea, vomiting, transient femoral nerve palsy, any signs, and symptoms of bowel perforation will be noted.

Conditions
Analgesia
Being tested
General anesthesia, Ilioinguinal, iliohypogastric nerve blocks, TAP block, Quadratus lumborum block
Medical subject headings
Agnosia

What participants receive

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

  • General anesthesiaOther

    All patients undergoing ceaserian section under general anesthesia

  • Ilioinguinal, iliohypogastric nerve blocksOther

    In ilioinguinal-iliohypogastric block group, the probe will be placed medial to the lateral one-third of the line joining the umbilicus and the anterior superior iliac spine (ASIS). The anterior superior iliac crest, iliacus muscle, internal oblique, transverses abdominis, and the ILIH nerves between them will be identified. After appreciating the sonoanatomy, the ILIH nerve will be approached with the 23-gauge Quincke spinal needle through in-plane technique and 10 ml of 0.25% bupivacaine will be injected all around and the drug spread will be appreciated.

  • TAP blockOther

    In TAP block group, the probe will be placed perpendicular to the mid-axillary line between the iliac crest and the subcostal margin and the three abdominal muscle layers will be identified, and the transverses abdominis plane will be located between the internal oblique and the transverse abdominis muscle. The TAP will be approached through in-plane technique using a 23-gauge Quincke spinal needle attached to a 20 ml syringe of 0.25% bupivacaine will be injected and the drug spread in the plane will be observed.

  • Quadratus lumborum blockOther

    For the QLB, the transducer will be placed at the level of the anterosuperior iliac spine and will move cranially until the 3 abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border was visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the quadratus lumborum muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the middle layer of he thoracolumbar fascia. The needle (21 gauge) will be inserted in plane from anterolateral to posteromedial. The optimal point of injection for the QL block will be determined over the lumbar interfacial triangle using hydrodissection.

Study groups in NCT05617482
Study groupRoleWhat they receive
Ultrasound guided ilioinguinal, iliohypogastric TAP blockActive comparatorIn ilioinguinal-iliohypogastric block group, the probe will be placed medial to the lateral one-third of the line joining the umbilicus and the anterior superior iliac spine (ASIS). The anterior superior iliac crest, iliacus muscle, internal oblique, transverses abdominis, and the ILIH nerves between them will be identified. After appreciating the sonoanatomy, the ILIH nerve will be approached with the 23-gauge Quincke spinal needle through in-plane technique and 10 ml of 0.25% bupivacaine will be injected all around and the drug spread will be appreciated.
Receives: Other: General anesthesia; Other: Ilioinguinal, iliohypogastric nerve blocks
Ultrasound guided transversus abdominis plane blockActive comparatorThe transducer will be placed at between the lower rib margin and the iliac crest, the 23-gauge Quincke spinal needle needle passed through the external oblique and internal oblique muscle till reaching the transversus abdominis sheet. 20 ml of 0.25% bupivacaine will be injected
Receives: Other: General anesthesia; Other: TAP block
Ultrasound guidedQuadratus lumborum blockActive comparatorThe transducer will be placed at the level of the anterosuperior iliac spine and will move cranially until the 3 abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border was visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the quadratus lumborum muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the middle layer of he thoracolumbar fascia. The needle (21 gauge) will be inserted in plane from anterolateral to posteromedial. The optimal point of injection for the QL block will be determined over the lumbar interfacial triangle using hydrodissection.
Receives: Other: General anesthesia; Other: Quadratus lumborum block

What is being measured

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

  1. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 2 hours postoperatively

  2. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 4 hours postoperatively

  3. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 6 hours postoperatively

  4. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 10 hours postoperatively

  5. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 12 hours postoperatively

  6. The quality of analgesia

    The quality of analgesia was assessed by NRS (unidimensional 11-point pain scale ranging from 0 to 10 with 0 no pain, 10 being severe pain, and the patients will be asked to mark the pain score on the scale)

    Measured: 24 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 posted15 Nov 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617482
Sponsor's protocol ID
35633/8/22
Status last verified
Nov 2022
First submitted
7 Nov 2022
Last updated
15 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing General anesthesia, Ilioinguinal, iliohypogastric nerve blocks and TAP block in people with Analgesia, run by Tanta University.

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 3 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

The quality of analgesia (time frame: 2 hours postoperatively). The study lists 6 primary outcomes in all. 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 15 Nov 2022.

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