Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Phase IV Recruiting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01542697
• Other study ID #: 698/067/068
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2012
• Last updated: February 27, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: B.P. Koirala Institute of Health Sciences
• Contact: Sujata Niroula, MD
• Phone: 00977-9842108624
• Email: drsujataniroula[@]gmail.com
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Interventional

Clinical Trial Summary

intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.

Description:

Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: ASA I-II

Exclusion Criteria: history of

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• intraperitoneal nebulisation of magnesium sulphate
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline

Locations

Country	Name	City	State
Nepal	routine operation theatre of BPKoirala	Dharan

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (2)

Abdel - Raouf M, Amer H. Postoperative analgesic effects of intraperitoneal NMDA receptor antagonist (ketamine and magnesium sulphate )in patients undergoing laparoscopic cholecystectomy .Eg J Anaesth. 2004;20: 107-11

Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of analgesic request	time to first analgesic request is taken as duration of effective analgesia; number of analgesic request in first 24 hours were also counted	24 hour	No
Secondary	VAS score	Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever	first complaint of pain, 6 hrs, 12 hrs, 24 hrs	No
Secondary	nausea and vomiting		24 hrs	No
Secondary	respiratory rate		24 hrs	No
Secondary	sedation		24hrs	No