NCT01902108

Brief Summary

The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

July 7, 2013

Last Update Submit

December 6, 2015

Conditions

Post-operative Pain

Keywords

clonidinebupivacainepost-operative painarthrodesisdiscectomylocal infiltration

Outcome Measures

Primary Outcomes (1)

  • Mean Area under curve

    Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10.

    From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h

Secondary Outcomes (3)

  • Area under Curve (AUC) of pain

    Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8

  • Daily rescue opiates consumption

    From the day of surgery till the 3rd postoperative day

  • Global subjective patient satisfaction of post-operative wound pain control

    Assessed at the end of follow-up on Day 8

Study Arms (2)

Clonidine

EXPERIMENTAL

Clonidine 150μg added to bupivacaine in a local infiltration before wound incision

Drug: Clonidine

Bupivacaine

ACTIVE COMPARATOR

Bupivacaine 0.25 % alone in the wound infiltration

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Bupivacaine
ClonidineDRUG

Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Clonidine

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First (not recurrent) posterior spinal surgery at the operated site
  • American Society of Anesthesiologists class I or II (operative risk)

You may not qualify if:

  • Allergy to local anesthetics or to clonidine
  • Pregnancy
  • Raynaud's syndrome
  • Thromboangiitis obliterans
  • History of substance abuse
  • Current treatment with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de france Hospital

Beirut, 16-6830, Lebanon

Location

Related Publications (1)

  • Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, Moussa R, Rizk T, Nohra G, Okais N, Samaha E, Maarrawi J. Bupivacaine Field Block With Clonidine for Postoperative Pain Control in Posterior Spine Approaches: A Randomized Double-Blind Trial. Neurosurgery. 2018 Jun 1;82(6):790-798. doi: 10.1093/neuros/nyx313.

    PMID: 28973650DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAnkylosis

Interventions

BupivacaineClonidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph Maarrawi, MD, PhD

    Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor : Researcher - Pain Specialist - Neurosurgeon

Study Record Dates

First Submitted

July 7, 2013

First Posted

July 18, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

LE(1)