NCT04689633

Brief Summary

The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any 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 Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

March 4, 2021

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

December 29, 2020

Last Update Submit

March 2, 2021

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • time of first postoperative analgesic request

    first time that patient need analgesia and visual analogue scale more than 3

    24 hours

Study Arms (3)

Quadratus lumborum block

ACTIVE COMPARATOR

received bilateral ultrasound-guided Quadratus lumborum block using 20 ml bupivacaine 0.25% on each side

Procedure: nerve block

Erector spinae block

ACTIVE COMPARATOR

received bilateral ultrasound-guided erector spinae block using 20 ml bupivacaine 0.25% on each side

Procedure: nerve block

Control

NO INTERVENTION

didn't received any block

Interventions

nerve blockPROCEDURE

bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest

Erector spinae blockQuadratus lumborum block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia

You may not qualify if:

  • Allergy to studed drugs
  • morbid obesity
  • patient refusal
  • infection at the side of the bolck
  • emergency laparoscopic cholecystectomy
  • if laparoscopic procedure converted to open

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, 61111, Egypt

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Abeer Hassaneen, MD

    Assistant professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 30, 2020

Study Start

April 15, 2019

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

March 4, 2021

Record last verified: 2018-12

Locations

EG(1)