Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

Phase 2

Completed

• Conditions: Gynecologic Laparoscopic Surgery
• Interventions: Drug: intrathecal Mg sulfate.; Drug: intrathecal bupivacaine 15 mg.

• Registration Number: NCT02671227
• Lead Sponsor: Assiut University

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
surgeon satisfaction (scale from 1 to 10) .	intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).	surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.

Secondary Outcome Measures

Name	Time	Method
postoperative pain management (VAS score).	postoperative for 6 hours.	Visual Analog Scale (VAS score).

Trial Locations

Locations (1)

Asiut university hospital; 🇪🇬 Asiut, Egypt