Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery

Hysterectomy Clinical Trial

Official title:

Effect of Perioperative Intravenous Infusion of Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption, Bowel Function and Recovery After Abdominal Gynaecological Surgery: a Randomised Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03363425
• Other study ID #: EE-2/04/31-01-2017
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 23, 2017
• Last updated: December 6, 2017
• Start date: November 14, 2017
• Est. completion date: November 2018

Study information

• Verified date: December 2017
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• women

• ASA I-II

• 30-70 years

• abdominal gynaecological surgery

Exclusion Criteria:

• patient's refusal

• contraindication to the use of local anesthetics

• body mass index >30 kg/m2

• history of cardiovascular diseases/ arrhythmias/ conduction abnormalities

• pregnant women

• significant renal or hepatic impairment

• insulin-dependent diabetes mellitus

• central nervous system disease or psychiatric diseases

• chronic use of opioids, steroids, clonidine (or other a2 agonist)

• use of drugs acting on the central nervous system or analgesics during the previous 2 weeks

• drug/alcohol abuse

• inability to comprehend the following pain assessment scale

Related Conditions & MeSH terms

• Hysterectomy
• Myomectomy
• Pain, Postoperative

Intervention

Drug:
• Lidocaine Iv
Lidocaine Iv
• Dexmedetomidine
dexmedetomidine iv
• Normal saline
placebo

Locations

Country	Name	City	State
Greece	Aretaieio University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic consumption 24 hours postop	morphine consumption from PCA	24 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	0 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	2 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	4 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	8 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	24 hours postoperatively
Secondary	postoperative pain	Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)	48 hours postoperatively