NCT02671227

Brief Summary

The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

January 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 27, 2017

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

January 24, 2016

Last Update Submit

January 26, 2017

Conditions

Gynecologic Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • surgeon satisfaction (scale from 1 to 10) .

    surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.

    intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).

Secondary Outcomes (1)

  • postoperative pain management (VAS score).

    postoperative for 6 hours.

Study Arms (2)

intrathecal bupivacaine + Mg sulfate

ACTIVE COMPARATOR

intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries.

Drug: intrathecal Mg sulfate.Drug: intrathecal bupivacaine 15 mg.

intrathecal bupivacaine

ACTIVE COMPARATOR

intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries.

Drug: intrathecal bupivacaine 15 mg.

Interventions

intrathecal Mg sulfate.DRUG

intrathecal Mg sulfate 50 mg.

intrathecal bupivacaine + Mg sulfate
intrathecal bupivacaine 15 mg.DRUG

intrathecal bupivacaine 15 mg.

intrathecal bupivacaineintrathecal bupivacaine + Mg sulfate

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female patient.
  • more than 18 years.
  • undergoing elective gynecologic laparoscopic surgeries.

You may not qualify if:

  • allergy to local anesthesia.
  • contraindication to spinal anesthesia.
  • Significant cardiac, liver or renal dysfunction.
  • Inability to informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asiut university hospital

Asiut, 71515, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and ICU

Study Record Dates

First Submitted

January 24, 2016

First Posted

February 2, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 27, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

EG(1)