NCT04965194

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

July 3, 2021

Last Update Submit

November 3, 2022

Conditions

Keywords

ESPBQLPBanalgesiapostoperative pain

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)

EXPERIMENTAL

20 ml of 0.25% bupivacaine will be administered to perform ESP block on each side

Procedure: erector spinae plane block

Quadratus lumborum plane block (QLPB)

EXPERIMENTAL

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.

Procedure: Quadratus lumborum plane block

Control group

PLACEBO COMPARATOR

patients received no regional block

Other: placebo

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.

Erector spinae plane block (ESPB)

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.

Quadratus lumborum plane block (QLPB)
placeboOTHER

patients received no regional block

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • Shadwa R Mohamed, MD

    Mina university hospital

    STUDY CHAIR
  • Ahmed H Mohamed

    Minia Universiry hospital

    STUDY DIRECTOR

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

Locations