Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy

NCT ID: NCT03393572

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-06-15

Brief Summary

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The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group BM

bupivacaine 0.25% plus magnesium sulphate.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

Magnesium sulphate.

Intervention Type DRUG

Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.

Group BN

bupivacaine 0.25% plus nalbuphine

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

nalbuphine

Intervention Type DRUG

Patients will receive intraperitoneal 5 mg nalbuphine

Interventions

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Bupivacaine 0.25%

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

Intervention Type DRUG

Magnesium sulphate.

Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.

Intervention Type DRUG

nalbuphine

Patients will receive intraperitoneal 5 mg nalbuphine

Intervention Type DRUG

Other Intervention Names

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opioid

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) physical status I and II
* scheduled for laparoscopic hysterectomy

Exclusion Criteria

* ASA physical status more than II
* Obesity (body mass index higher than 30 kg/ m2)
* History of chronic opioids intake
* Known hypomagnesaemia or hypermagnesaemia
* Chronic alcoholism
* Heart block
* Renal failure
* Patients with history of left ventricular failure
* Patients taking beta-blocking drugs
* Allergy to the study drugs
* if surgery changed to open hysterectomy,
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Ahmed Khairy Elbeialy

Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marwa Elbeialy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R49/2017

Identifier Type: -

Identifier Source: org_study_id

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