Condition category
Musculoskeletal Diseases
Date applied
28/02/2011
Date assigned
15/03/2011
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kalliopi Petroheilou

ORCID ID

Contact details

8 V. Mela str
Holargos
Athens
15561
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Sciatic lateral popliteal block with clonidine alone or clonidine plus 0.2% ropivacaine: effect on the intra- and postoperative analgesia for lower extremity surgery in children, a randomised prospective controlled study

Acronym

CLON, ROP

Study hypothesis

Our hypothesis was that clonidine alone or combined with 0.2% ropivacaine could produce a long lasting sciatic lateral popliteal block (SLPB) after foot and ankle surgery, adequate for the first postoperative day.

Ethics approval

Scientific Ethics Committee of General Children's Hospital, Penteli, Athens approved on 20/05/2008

Study design

Single-centre interventional prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Disturbances of Achilles tendon and club foot

Intervention

Between January 2009 to May 2010, 77 consecutive children, American Society of Anesthesiologists (ASA) physical status I and II, aged 5-14 years were scheduled for elective mild to moderate painful foot and ankle surgery.

66 children were randomly assigned to three groups by means of a computer generated table to receive either isotonic saline (n=21) or clonidine (n =23) or clonidine plus 0.2% ropivacaine (n=22), during performance of a sciatic lateral popliteal block (SLPB) plus femoral block. The investigators were blind to the group assignment. The placebo or the treatment solutions were prepared by the pharmacy and supplied to the Department of Anaesthesia in syringes labelled with predetermined code for each solution. There were two syringes for the SLPB and the femoral block respectively.

In the SLPB, the syringes contained
1. For the control group isotonic saline 10 ml plus 0.25 ml/kg and saline 0.13 ml/kg
2. For the clonidine group isotonic saline 10 ml plus 0.25 ml/kg and clonidine 2 µg/kg (0.13 ml/kg) respectively
3. Finally in the clonidine plus 0.2% ropivacaine group the syringes contained 0.2% ropivacaine 10 ml plus 0.25 ml/kg (maximum 25 ml) and clonidine 2 µg/kg (0.13 ml/kg) respectively.

Similarly in the femoral block the syringes contained
1. For the control group isotonic saline: 0.4 ml/kg and 0.065 ml/kg respectively
2. For the clonidine group isotonic saline 0.4 ml/kg and clonidine 1µg/kg (0.065 ml/kg) respectively
3. For clonidine plus 0.2% ropivacaine group 0.2% ropivacaine 0.4 ml/kg and clonidine 1µg/kg (0.065 ml/kg) respectively. The maximum dose of 0.2% ropivacaine was decided to be 3.5 mg/kg and for clonidine 3 µg/kg.

In the anaesthetised children in the supine position, the SLPB was performed, using 100 mm or 50 mm, 21 gauge insulated stimulated needle. An additional femoral block became necessary for the use of tourniquet in the area around the thigh. After the performance of blocks a pneumatic tourniquet at 150 mmHg was applied to the mid-thigh.

Postoperative analgesia was assessed by by means of a color analogue scale (CAS). Patients with mild or moderate postoperative pain (CAS score > 30 to 45 mm and 46 to 55 mm respectively) received nalbuphine 0.2 mg/kg and 0.3 mg/kg respectively.

Intervention type

Drug

Phase

Not Applicable

Drug names

Clonidine, ropivacaine

Primary outcome measures

Time to first analgesic request of nalbuphine after the surgery by Kaplan- Meier analysis. Postoperative analgesia was assessed by means of a colour analogue scale (CAS). Pain CAS score at rest, was assessed in the recovery room (0), 2, 4, 6, 8, 18, 24 hours postoperatively and the tourniquet pain (0). Total number of rescue nalbuphine doses and the total amount of nalbuphine for the 24 hours observational period.

Secondary outcome measures

1. Classification of motor and sensory block
2. Restlessness based on dichotomous(yes or no)
3. Incidence of nausea and/or vomiting
4. Sedation level using a four-point scale
5. Children’s parents satisfaction score was assessed on the second postoperative day, using a numerical scale.

Overall trial start date

01/01/2009

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children who underwent Achilles lengthening
2. Children with club foot

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

77

Participant exclusion criteria

1. Children with neurologic or neuromuscular disease or problems in communication
2. Children’s parents refusal
3. Skin infection at the site of needle insertion

Recruitment start date

01/01/2009

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Greece

Trial participating centre

8 V. Mela str
Holargos, Athens
15561
Greece

Sponsor information

Organisation

The Pharmacy Department of General Children's Hospital (Greeece)

Sponsor details

8 Hippocratous str
P.Penteli
Athens
15236
Greece

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Anesthesiology & the Pharmacy Department of General Children's Hospital (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes