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

NCT03393572 | Completed Phase 4

• 1 other identifier: FMASU R49/2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Rescue analgesia time

  Time to first analgesia requirment(considering the extubation is the zero time)

  First 24 hours postoperatively

Secondary Outcomes (2)

• Visual analogue scale [VAS]

  First 24 hours postoperatively

• Total analgesic consumption

  First 24 hours postoperatively

Study Arms (2)

Group BM

ACTIVE COMPARATOR

bupivacaine 0.25% plus magnesium sulphate.

Drug: Bupivacaine 0.25%; Drug: Magnesium sulphate.

Group BN

ACTIVE COMPARATOR

bupivacaine 0.25% plus nalbuphine

Drug: Bupivacaine 0.25%; Drug: nalbuphine

Interventions

Bupivacaine 0.25% DRUG

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

Group BM; Group BN

Magnesium sulphate. DRUG

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

Group BM

nalbuphine DRUG

Patients will receive intraperitoneal 5 mg nalbuphine

Also known as: opioid

Group BN

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Marwa Elbeialy

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate; Nalbuphine; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 8, 2018
• Study Start: January 3, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 15, 2018
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

EG (1)