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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393572
• Other study ID #: FMASU R49/2017
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine 0.25%
Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
• Magnesium sulphate.
Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.
• nalbuphine
Patients will receive intraperitoneal 5 mg nalbuphine

Locations

Country	Name	City	State
Egypt	Marwa Elbeialy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rescue analgesia time	Time to first analgesia requirment(considering the extubation is the zero time)	First 24 hours postoperatively
Secondary	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)	First 24 hours postoperatively
Secondary	Total analgesic consumption	Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS = 4.Total diclofenac consumption will be recorded.	First 24 hours postoperatively