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

July 13, 2019 updated by: Marwa Ahmed Khairy Elbeialy, Ain Shams University

Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Marwa Elbeialy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group BM
bupivacaine 0.25% plus magnesium sulphate.
Drug: Bupivacaine 0.25%
Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
Drug: Magnesium sulphate.
Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.
Active Comparator: Group BN
bupivacaine 0.25% plus nalbuphine
Drug: Bupivacaine 0.25%
Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
Drug: nalbuphine
Patients will receive intraperitoneal 5 mg nalbuphine
Other Names:
  • opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesia time
Time Frame: First 24 hours postoperatively
Time to first analgesia requirment(considering the extubation is the zero time)
First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale [VAS]
Time Frame: First 24 hours postoperatively
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
First 24 hours postoperatively
Total analgesic consumption
Time Frame: First 24 hours postoperatively
Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.
First 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R49/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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