Skip to main content
Clinical Trials/CTRI/2024/07/070499
CTRI/2024/07/070499
Not yet recruiting
Phase 3

Comparison of External oblique intercostal plane block and Subcostal Transverse Abdominal plane block on intraoperative and postoperative analgesic effect in paediatric patients undergoing upper abdominal surgeries.

Institute of medical sciences1 site in 1 country55 target enrollmentStarted: August 1, 2024Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Institute of medical sciences
Enrollment
55
Locations
1
Primary Endpoint
1.To compare the postoperative NRS between the external oblique intercostal plane block and subcostal transverse abdominal plane block

Overview

Brief Summary

This study will be conducted in Department of anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi. After approval from hospital research and ethical committee, a Prospective Randomized study will be conducted on patients coming to Institute of Medical Sciences, BHU, Varanasi.

Once the patients are enrolled, they will be next seen on the day of surgery in the operation theatre. Before taking them into the theatre, the Sono anatomy of the patient’s TAP block area and EOA block area will be checked using a ultrasound machine. The patients will be randomized into either Group E or Group T. Randomization will be done using computer generated random number sequence. Allocation concealment will be done using serially numbered opaque sealed envelopes. The process of allocation will be done by a staff member who is not a part of the study group. There will be (66) such sealed opaque envelopes pre-designed with equal numbers of EOA block and TAP Block treatments.

One day prior to the scheduled surgery, all the patients will be instructed on how to evaluate their own pain by using a 10cm Numeric rating pain scale (0-no pain; 10- maximum pain). In the operating room, after attaching the standard ASA monitors and IV lines, the patient will be induced using standardized general anesthesia protocol as routinely followed in our department. IV induction along with muscle relaxation followed by endotracheal intubation will be done. Ventilation will be titrated to ETCO2 between 35-45 mm Hg. Analgesia maintained with Inj. Fentanyl 2mcg/ kg at induction. If one or both of the Heart rate and blood pressure goes more than 20% of the baseline, Injection fentanyl (0.5 mics/Kg) will be given intra-operatively.  Inj. PCM 15 mg/kg IV will be given to all the patients prior to skin incisions and no other painkillers will be administered. No local suture incision and line/ port site infiltration will be allowed. The Blocks will be given after induction.

 Group T:  The probe is placed initially below the xiphoid process to view the Linea alba and directed obliquely down the costal margin keeping the rectus abdominus muscle in view. The rectus abdominus and the underlying transverse abdominus muscles are identified. Needle is inserted in plane from medial to lateral and the tip is placed in the fascial plane between the rectus abdominus and transverse abdominus. 0.5 ml/Kg of 0.25% Levobupivacaine local anesthetic is injected into the plane and hydro dissection of the two muscles is observed.

Group E:

Patients positioned in the supine position with their ipsilateral arm abducted. A 12-15 MHz linear transducer was used for ultrasonography. With the proceduralist at the patient’s ipsilateral shoulder, the chest wall is systematically scanned. The transducer is placed in the sagittal plane between midclavicular and anterior axillary line at the level of 6th rib with the orientation marker directed cranially. Rib 6 can be identified either by placing the ultrasound transducer at the lower costal margin where the 10th rib is identified and by counting up or by identifying the 7th rib at the level of xiphoid process and then moving the transducer one rib up. Rotating the transducer so that the cranial end is directed slightly medially and caudal end laterally to produce a paramedian sagittal oblique view with the short axis view of the ribs approx. 1 to 2 cm lateral to the mid clavicular line. Advancing the needle in plane from superomedial to inferolateral direction through the EOM, the LA is placed between EOM and ICM at the caudal end of the 6th rib and between 6th and 7th rib. Hydro dissection of the two muscles between 6th and 7th ribs noted and needle is directed caudally toward the 8th rib chasing the LA.

The obtained data will be recorded and the results will be statistically analysed by appropriate statistical method. A p value of 0.05 will be considered as significant.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
7.00 Year(s) to 14.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Paediatric patients undergoing upper abdominal surgeries under general Anesthesia.

Exclusion Criteria

  • Allergy to local anaesthetic
  • Bleeding disorders
  • Localised infections
  • Neurological disorders
  • Respiratory / cardiac disease
  • Patients not giving consent
  • Patients with poly trauma (cardio thoracic/ CNS).

Outcomes

Primary Outcomes

1.To compare the postoperative NRS between the external oblique intercostal plane block and subcostal transverse abdominal plane block

Time Frame: 0 min,15 min, 30 mins, 60 mins, 2 hrs,6hrs,12 hrs and 24 hrs postoperatively

Secondary Outcomes

  • 1.To compare the hemodynamic stability intra operatively between external oblique intercostal plane and subcostal transverse abdominal plane block(Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate at baseline, 15 minutes, 30 minutes, 45 minutes , 60 minutes , 75 minutes , 90 minutes, 105 minutes, 120 minutes and fentanyl consumption intraoperatively.)
  • •To compare the parents satisfaction using five-point Likert scale in both the groups
  • 4. Time needed to perform technique (in minutes)(. It is defined as the time needed for adequate ultrasound visualization, needle introduction and drug injection (time from placement of ultrasound probe on the patient’s skin to the end of local anesthetic injection)

Investigators

Sponsor
Institute of medical sciences
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Gautham R

Institute of medical sciences, Banaras Hindu university

Study Sites (1)

Loading locations...

Similar Trials