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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691933
Enrollment
120
Registered
2023-01-20
Start date
2023-02-01
Completion date
2023-07-01
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Analgesia in Major Upper Abdominal Surgery

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.

Interventions

PROCEDUREBlock group

Patient will be subjected to bilateral external oblique intercostal plane block

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double blinded

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative morphine requirements for 24 hours24 hours postoperativelyVisual analogue score will be measured every 2 hours

Secondary

MeasureTime frameDescription
Pain assessment24 hours postoperativelyVisual analogue score will be assessed every 2hours postoperatively
Rescue analgesia24 hours postoperatively0.5 microgram/kg fentanyl will be given if VAS score more than 4
Side effects24 hours postoperativelyAny side effect related to fentanyl or block

Contacts

Primary ContactMohamed Abdelmawla, MD
M_abdelmawla12@alexmed.edu.eg+201114748411
Backup ContactMaha Ghanem, MD
Ghanemmaha@yahoo.com+20127498435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026