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Regional Block for Upper Abdominal Surgeries

A

Alexandria University

Status and phase

Not yet enrolling
Phase 3

Conditions

Perioperative Analgesia in Major Upper Abdominal Surgery

Treatments

Procedure: Block group
Procedure: Morphine infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05691933
0305400

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Mohamed Abdelmawla, MD; Maha Ghanem, MD

Data sourced from clinicaltrials.gov

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