CLONidine and ROPivacaine in peripheral nerve blocks in children

ISRCTN	ISRCTN90832436
DOI	https://doi.org/10.1186/ISRCTN90832436
Protocol serial number	N/A
Sponsor	The Pharmacy Department of General Children's Hospital (Greeece)
Funder	Department of Anesthesiology & the Pharmacy Department of General Children's Hospital (Greece)

Submission date: 28/02/2011
Registration date: 15/03/2011
Last edited: 24/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kalliopi Petroheilou
Scientific

8 V. Mela str
Holargos, Athens
15561
Greece

Study information

Primary study design	Interventional
Study design	Single-centre interventional prospective randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	CLON, ROP
Study objectives	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(s)	Scientific Ethics Committee of General Children's Hospital, Penteli, Athens approved on 20/05/2008
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Clonidine, ropivacaine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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. Childrens parents satisfaction score was assessed on the second postoperative day, using a numerical scale.
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	77
Total final enrolment	66
Key inclusion criteria	1. Children who underwent Achilles lengthening 2. Children with club foot
Key exclusion criteria	1. Children with neurologic or neuromuscular disease or problems in communication 2. Childrens parents refusal 3. Skin infection at the site of needle insertion
Date of first enrolment	01/01/2009
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Greece

Study participating centre

8 V. Mela str

Holargos, Athens
15561
Greece

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2012	24/01/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.