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OpenTrials
Completed

NCT Number: NCT03393572

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

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.

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Key information

Conditions

Anesthesia

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Marwa Elbeialy

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Bupivacaine 0.25%

Drug

Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%

Magnesium sulphate.

Drug

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

Nalbuphine

Drug

Patients will receive intraperitoneal 5 mg nalbuphine

Other names: opioid

Primary outcomes

  1. Rescue analgesia time

    Time frame: First 24 hours postoperatively

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

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2018
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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