NCT05617482

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

November 7, 2022

Last Update Submit

November 7, 2022

Conditions

Outcome Measures

Primary Outcomes (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)

    2 hours postoperatively

  • 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)

    4 hours postoperatively

  • 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)

    6 hours postoperatively

  • 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)

    10 hours postoperatively

  • 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)

    12 hours postoperatively

  • 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)

    24 hours postoperatively

Study Arms (3)

Ultrasound guided ilioinguinal, iliohypogastric TAP block

ACTIVE COMPARATOR

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.

Other: General anesthesiaOther: Ilioinguinal, iliohypogastric nerve blocks

Ultrasound guided transversus abdominis plane block

ACTIVE COMPARATOR

The 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

Other: General anesthesiaOther: TAP block

Ultrasound guidedQuadratus lumborum block

ACTIVE COMPARATOR

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.

Other: General anesthesiaOther: Quadratus lumborum block

Interventions

All patients undergoing ceaserian section under general anesthesia

Ultrasound guided ilioinguinal, iliohypogastric TAP blockUltrasound guided transversus abdominis plane blockUltrasound guidedQuadratus lumborum block

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.

Ultrasound guided ilioinguinal, iliohypogastric TAP block

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.

Ultrasound guided transversus abdominis plane block

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.

Ultrasound guidedQuadratus lumborum block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All patients will be informed about the three tyoes of nerve blocks; the ultrasound guided ilioinguinal, iliohypogastric nerve blocks, TAP block and quadratus lumborum block. and will sign that they agree to have any one of them according to randomization. Also the outcome assessor will be unaware about the type of nerve block given to the patient.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

December 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11