Study to compare an injection given in lower back with injections given in outer layer of abdomen in children undergoing lower abdominal surgery for pain scores.

Not yet recruiting

• Conditions: Undergoing elective Inguinal region surgeries

• Registration Number: CTRI/2017/12/010988
• Lead Sponsor: Post graduate institute of medical education and research

Brief Summary

**Aim of study**

We hypothesize that ultrasound guided nerve block (TAP and IL/IH) will provide better post operative analgesia as compared to CEB for inguinal region surgeries in children.

We would enroll American Society of Anesthesiologists physical status I–II patients aged between 6 months and 8 years scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy). Written informed consent for study procedures will be obtained from all parents.

Group C = caudal block group (receive 0.75ml/kg of 0.2% ropivacaine)

Group T = usg guided TAP block group (receive 0.3ml/kg of 0.2% ropivacaine)

Group I = usg guided IL/IH nerve block (receive 0.1ml/kg of 0.2% ropivacaine)

All patients will receive standard general anaesthesia

Block procedure-

USG IL/IH nerve block-

Using 6-13 Hz ultrasound probe block will be performed keeping the probe cephalad to the anterior superior iliac (ASIS) crest parallel to the line joining umbilicus and ASIS. After visualisation of the IL/IH nerves between inferior oblique and transversus Abdominis muscles, using in plane technique, 22 G hypodermic needle will be introduced, tip of the needle would be followed and hydrodissection with saline would be done for confirmation and local anaesthetic (0.1ml/kg of 0.2% ropivacaine) will be injected such that it surrounds the nerves.

CEB

Patient would be placed in the left lateral position. The sacral hiatus between the sacral cornu would be palpated. With 23�’G short needle sacral puncture would be made with the bevel toward the abdomen at a 45�’degree angle. When the sacrococcygeal ligament seemed to have been punctured, the needle would be tilted more toward the skin surface and inserted 2�’3�’mm deeper. Negative aspiration would confirm any inadvertent blood vessel or dural puncture. Confirming, 0.75ml/kg of 0.2% ropivacaine would be injected in 2ml aliquots after intermittent careful negative aspirations.

USG TAP block

Ultrasound probe (6-13Hz) would be kept cephalad to the ASIS keeping the probe parallel to line joining umbilicus and ASIS, keeping the probe at the anterior axillary line level, using hypodermic needle 22G using in plane technique needle will be inserted till the tip of the needle reaches interface between inferior oblique and transversus Abdominis and hydrodissection will be done using saline after confirmation local anaesthetic (0.3ml/kg of 0.2% ropivacaine) will be injected.

The primary end point will be time to first rescue analgesia (paracetamol (PCM)). Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-12-27
• Study Start: 2018-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

We would enroll American Society of Anesthesiologists physical status I–II patients scheduled for elective unilateral inguinal surgery (inguinal herniotomy, hydrocelectomy,orchidopexy).

Exclusion Criteria

Exclusion criteria will include regional block refusal, known amide local anesthetic drug allergy, history of seizures or neurological, neuromuscular, psychiatric or blood clotting disorders, a history of clinically important renal, hepatic, cardiac, or neurological conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point will be time to first rescue analgesia (paracetamol (PCM)).	In PACU pain scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital. Pain will be assessed using FLACC Behavioural Pain Scale and Baker-Wong Faces Scale. If pain scores more than 6 they will be treated with injection fentanyl 0.5 microgram /kg and if pain scores more than 3 (FLACC)/more than 4(Baker Wong faces) injection paracetamol will be given

Secondary Outcome Measures

Name	Time	Method
Secondary parameters would be total intra operative fentanyl consumption, time in image acquisition and drug injection, total post operative PCM consumption, pain and sedation scores, total number of patients requiring rescue analgesia (PCM), incidence of post op nausea vomiting, parental satisfaction scores.	During the intraoperative course Vital parameters including heart rate, blood pressure and saturation will be recorded every 1minute for first 5minutes after block placement, at the time of skin incision, 5, 10 and 15 mins later. In PACU pain scoring and sedation scoring would be done every 15 minutes during the first hour in PACU and every 30 minutes for the next 3 hours in until discharge from the hospital.Incidence of nausea vomiting in PACU and parental satisfaction scores after 24 hours.

Trial Locations

Locations (1)

Department of anaesthesia and intensive Care; 🇮🇳 Chandigarh, CHANDIGARH, India

Department of anaesthesia and intensive Care

🇮🇳Chandigarh, CHANDIGARH, India

Dr Anudeep Jafra

Principal investigator

9888027699

anu_gmch@yahoo.co.in