Ultrasound-guided Erector Spinae Block Versus Quadratus Lumborum Block for Laparotomies
1 other identifier
interventional
60
1 country
1
Brief Summary
The study aimed to compare the effect of ESP block and QL block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for laparotomies. This prospective randomized controlled study will be done after obtaining ethics committee's permission and written informed consent of the patients 60 adult patients aged 18-60 years scheduled for open laparotomies under general anesthesia will be included in this study. According to the used technique, the patients will be randomly allocated into 3 parallel equal groups (20 patients in each one). Group I (ES group): the patients will receive bilateral ESP block. Group II (QL group): the patients will receive bilateral QL block. Group III (control group): the patients will not receive any regional block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedNovember 4, 2022
November 1, 2022
9 months
July 3, 2021
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total analgesic consumption
total fentanyl consumption as rescue analgesia
24 hours
Secondary Outcomes (3)
Time of first analgesic request.
24 hours
dynamic Visual analogue pain score
24 hours
resting Visual analogue pain score
24 hours
Study Arms (3)
Erector spinae plane block (ESPB)
EXPERIMENTAL20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side
Quadratus lumborum plane block (QLPB)
EXPERIMENTALThe injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Control group
PLACEBO COMPARATORpatients received no regional block
Interventions
Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The "shamrock sign" is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1.
Eligibility Criteria
You may qualify if:
- Aged 18-60 years.
- ASA I-II.
- Both sexes.
- Open laparotomies.
You may not qualify if:
- Patient refusal
- Allergy to local anesthetics
- BMI \>40 kg/m2
- Bleeding diathesis or history of anticoagulant use.
- Psychiatric diseases.
- Infection of the skin at the site of needle punctures area.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia University Hospital
Minya, Minya Governorate, 61111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shadwa R Mohamed, MD
Mina university hospital
- STUDY DIRECTOR
Ahmed H Mohamed
Minia Universiry hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
July 3, 2021
First Posted
July 16, 2021
Study Start
July 15, 2021
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
November 4, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share