Pain relief for children who are undergoing hernia surgeries, using a landmark technique or using ultrasound guidance
| ISRCTN | ISRCTN10599628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10599628 |
| Secondary identifying numbers | IEC/1/942/2019 |
- Submission date
- 02/09/2022
- Registration date
- 16/09/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Caudal epidural block is a popular regional anaesthetic technique in children undergoing infraumbilical surgeries (surgery below the navel). The aim of this study is to compare overall block success rates between the conventional and ultrasound-guided methods of caudal blocks. Other objectives are to compare block performance time and the number of attempts when using the two techniques.
Who can participate?
Children aged 1-8 years belonging to ASA physical status grades 1 and 2, undergoing elective inguinal hernial surgeries under general anaesthesia with caudal blocks.
What does the study involve?
Participants were divided into two groups and underwent caudal blocks either by the conventional landmark technique, or by the ultrasound-guided method. The child is given general anaesthesia as per standard practice and then given the caudal block for analgesia.
What are the possible benefits and risks of participating?
Participating in the study would ensure that the child will be pain-free during the surgery and postoperatively. As it is a commonly done procedure for pain relief, risks would include the usual risks involved in the caudal procedure. There is no higher than normal risk if participating in this study.
Where is the study run from?
St John's Medical College and Hospital (India)
When is the study starting and how long is it expected to run for?
October 2019 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mythreyi Muthu Krishnan, mythu.apr24@gmail.com
Dr Anjali T. M. Ollapally, dr.anjaliollapally@gmail.com
Contact information
Scientific
Dept. Of Anaesthesiology
St John's Medical College and Hospital
Bangalore
560034
India
| Phone | +91 80-22065502 |
|---|---|
| dr.anjaliollapally@gmail.com |
Principal Investigator
Dept. Of Anaesthesiology
St John's Medical College and Hospital
Bangalore
560034
India
| Phone | +91 80-22065502 |
|---|---|
| mythu.apr24@gmail.com |
Study information
| Study design | Single centre interventional randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42319_PIS.pdf |
| Scientific title | Ultrasound-guided versus conventional caudal block in children |
| Study acronym | USG-C |
| Study objectives | The success rate of ultrasound-guided caudal block is superior to the conventional landmark technique |
| Ethics approval(s) | Approved 30/10/2019, Institutional Ethics Committee (St John's Medical College and Hospital, Sarjapur road, Bangalore 560034, India; +91 80-49466346; sjmc.ierb@stjohns.in), ref: 292/2019 |
| Health condition(s) or problem(s) studied | Intraoperative and postoperative analgesia among children undergoing elective inguinal hernia surgeries |
| Intervention | Sixty-four children aged 1-8 years belonging to ASA physical status groups 1 and 2 undergoing elective inguinal hernial surgery were studied. After induction of general anaesthesia, they were administered caudal blocks depending on the groups they were randomly allocated to using a computer-generated lot system: Group A (conventional) – 0.5 ml/kg of 0.25% Bupivacaine was injected after the needle entered the sacral canal Group B (USG) – 0.5 ml/kg of 0.25% Bupivacaine was injected right after the needle was visualised piercing the sacrococcygeal ligament in the longitudinal view. The children were monitored during surgery every 5 minutes for adequacy of analgesia. There was hemodynamic and respiratory monitoring in the Post Anesthesia Care Unit (as is customary for all general anaesthesia). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Overall block success rate, defined as the absence of significant motor movements at the time of surgical incision, or a significant increase in heart rate (HR)/respiratory rate (RR) |
| Secondary outcome measures | 1. Block performance time, calculated as the time period from identification of structures to the termination of injection of local anaesthetic 2. Number of attempts taken: if the patient is pricked with a needle and it is then removed, it is considered an attempt. The maximum number of attempts was three, the third attempt being made by another senior anaesthesiologist. |
| Overall study start date | 15/10/2019 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 64 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Between 1-8 years of age with no contraindications for caudal block 2. Scheduled for elective inguinal hernia surgeries 3. Belonging to ASA physical status 1 or 2 |
| Key exclusion criteria | 1. Consent not given for the procedure 2. Contraindications for caudal block |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 01/09/2021 |
Locations
Countries of recruitment
- India
Study participating centre
Bangalore
560034
India
Sponsor information
Hospital/treatment centre
Sarjapur Road
Bengaluru
560034
India
| Phone | +91 (0)80-22065502 |
|---|---|
| sjmc.ierb@stjohns.in | |
| Website | http://www.stjohns.in/ |
"ROR" |
https://ror.org/03qvjzj64 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 14/09/2022 | No | Yes | ||
| Results article | 01/08/2023 | 29/12/2023 | Yes | No |
Additional files
Editorial Notes
29/12/2023: Publication reference added.
14/09/2022: Trial's existence confirmed by the Institutional Ethics Committee (St John's Medical College and Hospital).
