Regional Block for Upper Abdominal Surgeries

Phase 3

Not yet recruiting

• Conditions: Perioperative Analgesia in Major Upper Abdominal Surgery
• Interventions: Procedure: Block group; Procedure: Morphine infusion

• Registration Number: NCT05691933
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25
• Study Start: 2023-02-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block group	Block group	Patients will be subjected to bilateral external oblique intercostal plane block
Opioid group	Morphine infusion	Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h

Primary Outcome Measures

Name	Time	Method
Postoperative morphine requirements for 24 hours	24 hours postoperatively	Visual analogue score will be measured every 2 hours

Secondary Outcome Measures

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