Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.

Pain, Postoperative Clinical Trial

Official title:

Effect of Acute Arterial Hypertension on Morphine's Requirements and Postsurgical Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897155
• Other study ID #: RIH_AP-UC-2012
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2013
• Last updated: July 8, 2013
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2013
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized clinical trial is to evaluate the effect of acute arterial hypertension maintained during surgery on morphine's requirements in patients undergoing laparoscopic cholecystectomy

Description:

The high arterial blood pressure has been correlated with an increase in pain threshold in animal and humans. One of the explanations to this phenomenon is a baroreceptor activity and vasopressin release at the level of spinal cord dorsal horn and hypothalamus.

As far as we know, there is only one study about the effect of chronic hypertension on postoperative pain and none with acute hypertension. We therefore decided to conduct a randomized controlled trial to evaluate the effect of acute hypertension on postoperative morphine's requirements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology patient classification status(ASA) I-II

• Between 20 and 60 years of age

• Programed for elective laparoscopic cholecystectomy

Exclusion Criteria:

• History of arterial hypertension

• Baseline blood pressure over 139/89

• Use of opioids and any analgesic drug during the last 24 hours before surgery

• Chronic use of nonsteroidal antiinflammatory

• BMI > 34.9

• History of drug or alcohol abuse

• Use of medications that interfere in the central nervous system

• Adverse reactions to the drugs used in the study

• Pregnancy

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disease
• Pain, Postoperative

Intervention

Other:
• SBP 20-30% over baseline
Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over the baseline. The upper limit of systolic blood pressure is 165 mmHg.
• SBP 20-30% under baseline
Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% below the baseline. The lower limit of systolic blood pressure is 75 mmHg

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad Catolica	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine requirement post laparoscopic cholecystectomy	Measure of morphine consumption during the first 24 postoperative hours in patients undergoing laparoscopic cholecystectomy.	First 24 hours postoperative	No
Secondary	Effects of acute hypertension in pain scores		First 24 hours postoperative	No