Ultrasound Quadratus Lumborum Block Vs Fascia Iliaca Block in Pediatrics Undergoing Hip Surgery .

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05282849

Collaborator

(none)

Enrollment

Location

Arms

2.4

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison between ultrasound guided transmuscular QL block and Fascia iliaca block in pediatric patients undergoing DDH surgery regarding the quality of pain control in the perioperative period..

Condition or Disease	Intervention/Treatment	Phase
Developmental Dysplasia of the Hip	Procedure: ultrasound guided fascia iliaca block Procedure: ultrasound guided quadratus lumborum block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ultrasound Guided Quadratus Lumborum Block Versus Fascia Iliaca Block in Pediatric Patients Undergoing Developmental Dysplasia of Hip Surgical Repair. A Randomized Comparative Study

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group F: ultrasound guided fascia iliaca block group	Procedure: ultrasound guided fascia iliaca block ultrasound guided fascia iliaca block anesthetizes variable combinations of the femoral nerve , lateral femoral cutaneous nerve , and obturator nerve, and is effective for many painful hip surgeries making it potentially useful for analgesia following Developmental Dysplasia of Hip (DDH) surgery.
Active Comparator: Group Q: ultrasound guided quadratus lumborum block group	Procedure: ultrasound guided quadratus lumborum block ultrasound-guided quadratus lumborum (QL) block provides perioperative somatic, even visceral analgesia for patients including pediatrics, undergoing abdominal or hip surgery. The local anesthetic injected adjacently into the quadrates lumborum muscle spreads in a medial and cranial direction under the crura and arcuate ligaments of the diaphragm, then into the thoracic paravertebral space anesthetizing the hip region

Arm

Intervention/Treatment

Active Comparator: Group F: ultrasound guided fascia iliaca block group

Procedure: ultrasound guided fascia iliaca block

ultrasound guided fascia iliaca block anesthetizes variable combinations of the femoral nerve , lateral femoral cutaneous nerve , and obturator nerve, and is effective for many painful hip surgeries making it potentially useful for analgesia following Developmental Dysplasia of Hip (DDH) surgery.

Active Comparator: Group Q: ultrasound guided quadratus lumborum block group

Procedure: ultrasound guided quadratus lumborum block

ultrasound-guided quadratus lumborum (QL) block provides perioperative somatic, even visceral analgesia for patients including pediatrics, undergoing abdominal or hip surgery. The local anesthetic injected adjacently into the quadrates lumborum muscle spreads in a medial and cranial direction under the crura and arcuate ligaments of the diaphragm, then into the thoracic paravertebral space anesthetizing the hip region

Outcome Measures

Primary Outcome Measures

Total 12 hours postoperative opioid consumption [from the time of transfer of the patient to the pacu at one hour intervals for 12 hours]
amount of morphine consumed as rescue analgesia in first 12 hours

Secondary Outcome Measures

Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale [from the time of transfer to the PACU, every hour for the first 24 hours postoperative]]
pain score of paitients in the post operative period
Side effects [from the time of transfer to the PACU, for the first 24 hours postoperative]
respiratory depression and postoperative nausea and vomiting
Total 24 hours postoperative opioid consumption [from the time of transfer of the patient to the pacu at one hour intervals for 24hours]
amount of morphine consumed as rescue analgesia in first 24hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children aged 2-12 years
Of both sexes
American society of anesthesiologist (ASA) physical status classification class I
Undergoing general anaesthesia for DDH surgery

Exclusion Criteria:

Parents' refusal of regional block
Duration of surgery over 120 min.
History of allergy to local anesthetics
Bleeding disorders (INR >1.4, Platelet count< 75000)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine Cairo university	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sherif Mohamed Abd El Moneim Soaida, MD, assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05282849

Other Study ID Numbers:

SMS2022-1

First Posted:

Mar 16, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sherif Mohamed Abd El Moneim Soaida, MD, assistant professor, Cairo University

ultrasound

quadratus lumborum

fascia iliaca

Additional relevant MeSH terms:

Developmental Dysplasia of the Hip

Hip Dislocation, Congenital

Study Results

No Results Posted as of Apr 15, 2022