NCT03459417

Brief Summary

Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 13, 2019

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

February 21, 2018

Last Update Submit

December 11, 2019

Conditions

Abdominal CancerAbdominal Pain

Outcome Measures

Primary Outcomes (1)

  • change pain sensation using VAS scores

    pain sensation using VAS scores with movement (0-10) 0=no pain 10=worst pain ever

    at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative

Secondary Outcomes (1)

  • change in MAP

    at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative

Study Arms (3)

intrathecal morphine+LA

ACTIVE COMPARATOR

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine.

Procedure: intrathecal morphine+LA

intrathecal morphine+LA+Mg sulp. 50

ACTIVE COMPARATOR

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 50 mg.

Procedure: intrathecal morphine+LA+ Mg sulp. 50

intrathecal morphine+LA+ Mg sulp.100

ACTIVE COMPARATOR

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 100 mg.

Procedure: intrathecal morphine+LA+ Mg sulp. 100

Interventions

intrathecal morphine+LAPROCEDURE

Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage. patients will receive intrathecal LA 15 mg (3 mL) (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 100 mg.

intrathecal morphine+LA
intrathecal morphine+LA+ Mg sulp. 50PROCEDURE

Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal +0.5 mg preservative free morphine + magnesium sulphate 50 mg.

intrathecal morphine+LA+Mg sulp. 50
intrathecal morphine+LA+ Mg sulp. 100PROCEDURE

Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal with 0.5 mg preservative free morphine + magnesium sulphate 100 mg.

intrathecal morphine+LA+ Mg sulp.100

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery

You may not qualify if:

  • significant coexisting, hepatorenal, or other end organ disease, obesity (BMI \> 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, 0020, Egypt

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

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

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 8, 2018

Study Start

January 1, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

December 13, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)