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Clinical Trials/CTRI/2024/03/063615
CTRI/2024/03/063615
Not yet recruiting
Phase 4

Comparison of analgesic efficacy of ultrasound guided External oblique Intercostal fascial Plane (EOI) Block versus Erector Spinae Plane (ESP) Block in adult patients undergoing open upper abdominal surgeries: A randomized controlled trial.

Aiims Patna1 site in 1 country50 target enrollmentStarted: March 17, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Aiims Patna
Enrollment
50
Locations
1
Primary Endpoint
To assess and compare 24-hour postoperative opioid consumption in ESP block group and

Overview

Brief Summary

This is randomized controlled study to compare analgesic efficacy of external oblique intercostal plane block and erector spinae plane block in adult patients undergoing open upper abdominal surgery using ultrasound machine.

Primary objective of this study to assess and compare 24-hour postoperative opioid consumption in External oblique intercostal plane block group and Erector spinae plane block  group.

All patients will be recruited one day prior to surgery and a detailed pre anaesthetic assessment will be done. The patients will be instructed to stay nil per oral (NPO) according to standard fasting guidelines prior to surgery.

After shifting the patients to operating room standard ASA monitors will be attached and baseline vitals like heart rate (HR), noninvasive blood pressure (NIBP), Electrocardiogram (ECG), oxygen

saturation (SpO2), and temperature will be monitored. General anaesthesia (GA) will be given using intravenous Fentanyl 2 μg/kg, Propofol 2 mg/kg and Atracurium 0.5 mg/kg. Paracetamol 15

mg/kg and Dexamethasone 6 mg IV would be administered to all patients.

An anesthesiologist with expertise executing blocks who has performed minimum 25 such blocks (who will be blinded to the collected data until the end of the trial) will perform the block

procedures. Both blocks will be done under strict aseptic conditions with ultrasound machines equipped with a high-frequency linear probe with a sterile sheath

Group A will receive US - guided External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine along with GA.

Group B: will receive US-guided Erector Spinae plane block External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine at T7 level along with GA.

Time of block performance(TBP) will be observed in each group. The TBP will be accepted as the time from the placement of the US probe on the skin to the administration of the injection and will be recorded by the anesthesia technician.

Anesthesia will be maintained with sevoflurane, oxygen and air with a target MAC of 1. Skin incision will be allowed 15 minutes after the injection of study solutions in both the groups.

Intraoperative any increase in HR/MAP more than 20% intraoperatively will be treated with

additional fentanyl doses of 0.5 mcg/kg. Total intraoperative fentanyl consumption will be noted in both groups. Intraoperatively MAP and HR will be recorded at 5, 30, 60, and 90 minutes afterskin incision and at the end of surgery. No local anesthetic will be used by the surgeon for infiltration in either of the groups.

At the end of surgery, all the patients will receive Injection Ondansetron 0.1mg/kg and reversal agent (Injection neostigmine 0.05mg/kg and injection glycopyrrolate 0.01mg/kg). The patient will

be shifted to the post anesthesia care unit (PACU) with oxygen supplementation by mask as per requirements. Postoperatively all patients will receive 15 mg/kg IV paracetamol every 6 hours.

Pain perception will be measured in the PACU at rest by using NRS (0–10) at 30 minutes, 2,4,8,12,16 and 24 hour

All patients enrolled in the study will be given a patient controlled analgesia (PCA) pump programmed for a demand-only mode with no basal rate; the program will deliver a bolus of fentanyl 25 micg with a maximum of 6 doses in an hour.

This study include adult patients age between 18- 75 years.  The calculated sample size is 50. Expected duration of surgery 1.5 years

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult patients 18 -75 years, American Society of Anesthesiologists-physical status (ASA-PS) I–II undergoing open upper abdominal surgery with Unilateral Subcostal incision Patients willing to give written informed consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To assess and compare 24-hour postoperative opioid consumption in ESP block group and

Time Frame: To assess and compare 24-hour postoperative opioid consumption in ESP block group and | EOI block group via numerical rating scale (NRS) at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours and 24 hours.

EOI block group via numerical rating scale (NRS)

Time Frame: To assess and compare 24-hour postoperative opioid consumption in ESP block group and | EOI block group via numerical rating scale (NRS) at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours and 24 hours.

Secondary Outcomes

  • Time to first rescue analgesia.(Numerical rating scores of pain (rest and cough) in first 24-hour postoperative period)

Investigators

Sponsor
Aiims Patna
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Angad Maurya

All India Institute of Medical Sciences, Patna

Study Sites (1)

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