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CompletedNCT03393572Updated Jul 16, 2019

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

A Phase 4 interventional study of Bupivacaine 0.25% and Magnesium sulphate. in Anesthesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Anesthesia

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03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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,
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Group BM

    bupivacaine 0.25% plus magnesium sulphate.

    Drug: Bupivacaine 0.25% · Drug: Magnesium sulphate.

  • Active comparator
    Group BN

    bupivacaine 0.25% plus nalbuphine

    Drug: Bupivacaine 0.25% · Drug: nalbuphine

Interventions

  • DrugBupivacaine 0.25%

    Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

  • DrugMagnesium sulphate.

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

  • Drugnalbuphine

    Patients will receive intraperitoneal 5 mg nalbuphine

    Also known as: opioid

05

What researchers measure

Primary outcomes

  1. Rescue analgesia time

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

    Time frame: First 24 hours postoperatively

Secondary outcomes

  1. Visual analogue scale [VAS]

    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)

    Time frame: First 24 hours postoperatively

  2. Total analgesic consumption

    Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.

    Time frame: First 24 hours postoperatively

06

Study locations

1 site
  • Marwa Elbeialy
    Cairo, 11591, Egypt
07

Registry details

Key details

Study ID
NCT03393572
Lead sponsor
Ain Shams University
Responsible party
Marwa Ahmed Khairy Elbeialy (Lecturer of Anesthesia, Ain Shams University) — Principal investigator
First posted
Jan 8, 2018
Start date
Jan 3, 2018
Primary completion
Jun 5, 2018
Completion
Jun 15, 2018
Last update
Jul 16, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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