NCT02550444

Brief Summary

The purpose of this study is to evaluate effects of intravenous clonidine in acute and chronic post-cesarean pain, possible adverse effects over mother-newborn pair, in comparison to intrathecal adjuvant clonidine and placebo.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 4, 2015

Last Update Submit

October 31, 2017

Conditions

Pregnancy

Keywords

ClonidineAnesthesia, Obstetrical

Outcome Measures

Primary Outcomes (3)

  • Umbilical Artery Blood Gas Analysis - pH

    pH

    Right after born

  • Umbilical Artery Serum Lactate

    Lactate

    Right after born

  • Newborn Apgar Score

    Score can vary from 0 to 10.

    First, Fifth and Tenth minutes after born

Secondary Outcomes (4)

  • Maternal heart rate

    Intraoperatively

  • Maternal blood pressure variation

    Intraoperatively

  • Numerical verbal scale for pain

    6, 12, 24 and 48 hours after cesarean section

  • Maternal sedation

    Intraoperatively

Study Arms (3)

Control

PLACEBO COMPARATOR

Intravenous and intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Drug: Placebo

Intrathecal Clonidine

EXPERIMENTAL

Intrathecal Adjuvant Clonidine 75 mcg; Intravenous Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Drug: Intrathecal Clonidine

Intravenous Clonidine

EXPERIMENTAL

Intravenous Clonidine 75 mcg; Intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Drug: Intravenous Clonidine

Interventions

Intrathecal ClonidineDRUG

Intrathecal Adjuvant Clonidine 75 mcg; Intravenous Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Also known as: Clonidine
Intrathecal Clonidine
Intravenous ClonidineDRUG

Intravenous Clonidine 75 mcg; Intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Also known as: Clonidine
Intravenous Clonidine
PlaceboDRUG

Intravenous and intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Also known as: Saline
Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • term pregnancy;
  • elective cesarean (no labor).

You may not qualify if:

  • multiple pregnancy;
  • moderate or several systemic disease, categorized as American Society of Anesthesiology physical status (ASA) higher or equal to 3;
  • contraindications for spinal anesthesia;
  • contraindications for the drugs involved in the study;
  • uncontrolled high blood pressure or diabetes mellitus in need of insulin therapy;
  • intravenous psychotropic drugs users;
  • previously known malformation on the fetus;
  • patients with previous history of chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Mayor S. 23% of babies in England are delivered by caesarean section. BMJ. 2005 Apr 9;330(7495):806. doi: 10.1136/bmj.330.7495.806-a. No abstract available.

    PMID: 15817536BACKGROUND

  • Eisenach JC, De Kock M, Klimscha W. alpha(2)-adrenergic agonists for regional anesthesia. A clinical review of clonidine (1984-1995). Anesthesiology. 1996 Sep;85(3):655-74. doi: 10.1097/00000542-199609000-00026. No abstract available.

    PMID: 8853097BACKGROUND

  • Filos KS, Goudas LC, Patroni O, Polyzou V. Intrathecal clonidine as a sole analgesic for pain relief after cesarean section. Anesthesiology. 1992 Aug;77(2):267-74. doi: 10.1097/00000542-199208000-00008.

    PMID: 1642346BACKGROUND

  • Fernandes HS, Bliacheriene F, Vago TM, Corregliano GT, Torres ML, Francisco RP, Ashmawi HA. Clonidine Effect on Pain After Cesarean Delivery: A Randomized Controlled Trial of Different Routes of Administration. Anesth Analg. 2018 Jul;127(1):165-170. doi: 10.1213/ANE.0000000000003319.

    PMID: 29596102DERIVED

MeSH Terms

Interventions

ClonidineSodium Chloride

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hermann S Fernandes, MD

    Clinics Hospital of University of São Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 15, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

June 1, 2016

Last Updated

November 1, 2017

Record last verified: 2015-09