Regional Block for Upper Abdominal Surgeries

Ultrasound Guided External Oblique Intercostal Plane Block for Perioperative Analgesia in Major Upper Abdominal Surgery: Prospective Randomized Controlled Study

Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.

Regional blocks allow better pain control and avoid side effects of opioid based pain control

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Analgesia in Major Upper Abdominal Surgery
• Intervention / Treatment: Procedure: Block group; Procedure: Morphine infusion

Detailed Description

Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study

Introduction:

Pain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.

Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.

The external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.

The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.

Patients and Methods:

A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamed Abdelmawla, MD; Phone Number: +201114748411; Email: M_abdelmawla12@alexmed.edu.eg
• Study Contact Backup: Name: Maha Ghanem, MD; Phone Number: +20127498435; Email: Ghanemmaha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing upper abdominal surgeries

Exclusion Criteria:

• BMI above 40

  • allergy for drugs used
  • complicated cases
  • patient refusal
  • chronic opioid use
  • cognitive dysfunction
  • chronic kidney disease
• Liver failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block group; Patients will be subjected to bilateral external oblique intercostal plane block	Procedure: Block group; Patient will be subjected to bilateral external oblique intercostal plane block
Active Comparator: Opioid group; Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h	Procedure: Morphine infusion; Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine requirements for 24 hours	Visual analogue score will be measured every 2 hours	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Any side effect related to fentanyl or block	24 hours postoperatively
Pain assessment	Visual analogue score will be assessed every 2hours postoperatively	24 hours postoperatively
Rescue analgesia	0.5 microgram/kg fentanyl will be given if VAS score more than 4	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Hughes M, McNally S, McKeown DW, Wigmore S. Effect of analgesic modality on outcome following open liver surgery: a systematic review of postoperative analgesia. Minerva Anestesiol. 2015 May;81(5):541-56. Epub 2014 Jun 11.
• Rosero EB, Cheng GS, Khatri KP, Joshi GP. Evaluation of epidural analgesia for open major liver resection surgery from a US inpatient sample. Proc (Bayl Univ Med Cent). 2014 Oct;27(4):305-12. doi: 10.1080/08998280.2014.11929141.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 0305400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared on request
• IPD Sharing Time Frame: One year
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No