Dexmedetomidine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02031510
• Date of registration: 07/01/2014
• Prospective Registration: No
• Primary sponsor: Dammam University
• Public title: Dexmedetomidine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
• Scientific title: Dexmedetomidine as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Multicentre Study
• Date of first enrolment: January 2014
• Target sample size: 195
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02031510
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Saudi Arabia

Contacts

• Name: Abdulmohsen A Al Ghamdi, MD
• Affiliation: Chairman of Anesthesiology Dept

Key inclusion & exclusion criteria

Inclusion Criteria:

- American Society of Anesthesiologists class I and II patients

- general anaesthesia

Exclusion Criteria:

- cardiovascular disease

- respiratory disease

- neurological disease

- renal disease

- hepatic disease

- hormonal disease

- pregnancy

- body mass index > 35 kg/m2)

- smokers

- alcohol abuse

- use of antipsychotics

- communication barriers

- local anesthetics allergy

- chronic use of opioids

- use of nonsteroidal anti-inflammatory drug use during the 24 hours immediately
preceding surgery

- coagulation disorders

- infection at the needle insertion

- conversion of laparoscopic to open cholecystectomy



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Elective Laparoscopic Cholecystectomy

Intervention(s)

Drug: bupivacaine-dexmedetomidine

Drug: bupivacaine

Drug: placebo

Primary Outcome(s)

postoperative 24-hours cumulative morphine consumption [Time Frame: for 24 hours after surgery]

Secondary Outcome(s)

cumulative use of fentanyl [Time Frame: for 2 hours during surgery]

postoperative pain at rest [Time Frame: for 24 hours after surgery]

postoperative pain on movement [Time Frame: for 24 hours aftersurgery]

Time to bowel recovery [Time Frame: for 24 hours after surgery]

sedation scores [Time Frame: For 24 hours after surgery]

Secondary ID(s)

Anesth-Nov13(2)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mansoura University