NCT02539693

Brief Summary

Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption. Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

5.5 years

First QC Date

September 1, 2015

Last Update Submit

January 14, 2022

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Compare analgesic consumption using questionnaire

    Patients will be followed-up after the operation, an expected average of five days

Secondary Outcomes (2)

  • Time needed to return to normal activity noted by calling the patients

    Patients will be followed-up after the operation, an expected average of five days

  • Pain using verbal numeric rating scale (VNRS)

    Patients will be followed-up after the operation, an expected average of five days

Study Arms (2)

Clonidine 75

EXPERIMENTAL

Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).

Drug: Clonidine 75 µg/mL in sacrococcygeal blockDrug: LidocaineProcedure: Pilonidal sinus

Clonidine 150

EXPERIMENTAL

Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).

Drug: Clonidine 150 µg/mL in sacrococcygeal blockDrug: LidocaineProcedure: Pilonidal sinus

Interventions

Clonidine 75 µg/mL in sacrococcygeal blockDRUG

Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture

Clonidine 75
Clonidine 150 µg/mL in sacrococcygeal blockDRUG

Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture

Clonidine 150
LidocaineDRUG

3 ml lidocaine 1% is injected at each block site

Clonidine 150Clonidine 75
Pilonidal sinusPROCEDURE

Removal of pilonidal sinus

Clonidine 150Clonidine 75

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients scheduled for pilonidal sinus surgery

You may not qualify if:

  • Patients who have allergic reactions to lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

ClonidineLidocaine

Condition Hierarchy (Ancestors)

CystsNeoplasms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Zoher Naja, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoher Naja, MD

CONTACT

+9611636000zouhnaja@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson of Anesthesia and Pain Management Department

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

October 1, 2016

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

LE(1)