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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897155

Enrollment

Registered

2013-07-11

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disease, Pain, Postoperative

Keywords

analgesia, postoperative;, analgesics opioid;, hyperalgesia;, remifentanil;, hypertension.

Brief 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

Detailed 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.

Interventions

OTHERSBP 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.

OTHERSBP 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Morphine requirement post laparoscopic cholecystectomy	First 24 hours postoperative	Measure of morphine consumption during the first 24 postoperative hours in patients undergoing laparoscopic cholecystectomy.

Secondary

Measure	Time frame
Effects of acute hypertension in pain scores	First 24 hours postoperative

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026