Regional Block for Upper Abdominal Surgeries

NCT ID: NCT05691933

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-07-01

Brief Summary

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

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.

Conditions

Perioperative Analgesia in Major Upper Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Block group

Patients will be subjected to bilateral external oblique intercostal plane block

Group Type: ACTIVE_COMPARATOR

Block group

Intervention Type: PROCEDURE

Patient will be subjected to bilateral external oblique intercostal plane block

Opioid group

Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h

Group Type: ACTIVE_COMPARATOR

Morphine infusion

Intervention Type: PROCEDURE

Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h

Interventions

Block group

Patient will be subjected to bilateral external oblique intercostal plane block

Intervention Type: PROCEDURE

Morphine infusion

Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mohamed Abdelmawla, MD

Role: CONTACT

M_abdelmawla12@alexmed.edu.eg

+201114748411

Maha Ghanem, MD

Role: CONTACT

Ghanemmaha@yahoo.com

+20127498435

References

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.

Reference Type: BACKGROUND

PMID: 24918191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25484494 (View on PubMed)

Other Identifiers

0305400

Identifier Type: -

Identifier Source: org_study_id