NCT02533284

Brief Summary

Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

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

April 6, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

April 6, 2015

Last Update Submit

August 22, 2015

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • analgesia after laparoscopic cholecystectomy

    24 hours

Study Arms (3)

Magnesium sulfate group

EXPERIMENTAL

US guided TAP with magnesium sulfate

Drug: Magnesium SulfateDrug: bupevecaine

B group

EXPERIMENTAL

TAP bupevecaine

Drug: bupevecaine

C group

PLACEBO COMPARATOR

control TAP saline

Drug: saline

Interventions

Magnesium SulfateDRUG

preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).

Also known as: Group 1
Magnesium sulfate group
bupevecaineDRUG

US guided TAP using Bupevecaine 0.25 %

Also known as: group 2
B groupMagnesium sulfate group
salineDRUG

US guided TAP using placebo (saline)

Also known as: group3
C group

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA I, II for lap cholecystectomy

You may not qualify if:

  • ASA III, IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Central Study Contacts

Alrefaey Kandeel, MD

CONTACT

00201008158591refa3ey2@yahioo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 6, 2015

First Posted

August 26, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

EG(1)