A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries

Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment.

Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

External oblique intercostal plane (EOIP) block is a newly described block at which local anaesthetic (LA) is deposited in the interfascial plane deep to external oblique muscle at the sixth intercostal space. It provides blockade of the thoracoabdominal nerves at the level of T6 to T10.

In this study, the investigators compare between ultrasound (US) guided external oblique intercostal plane block and erector spinae plane block, in providing postoperative analgesia for upper abdominal surgeries

Study Overview

• Status: Not yet recruiting
• Conditions: Block
• Intervention / Treatment: Procedure: external oblique intercostal plane block; Procedure: erector spinae plane block

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with American Society of Anesthesiologists physical status (ASA) I and II.
• Both sex.
• 20 to 60 years old patients.
• upper abdominal surgeries.

Exclusion Criteria:

• Refusal of the patient to consent.
• Patients with ASA status III or IV
• Patients with bleeding disorders and coagulopathy (INR≥1.6 & PTT≥50 sec).
• Infection at the injection site.
• Allergy to local anesthetics.
• Patients with ages less than 20 or more than 60
• Patients with pre-existing myopathy or neuropathy.
• Patients with chronic pain syndromes.
• Patients with history of long acting opioids or steroids preoperatively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Active Comparator: external oblique intercostal plane block	Procedure: external oblique intercostal plane block; o EOIP Group (ŋ=25): Patients will receive ultrasound guided External oblique intercostal plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery.
Active Comparator: erector spinae plane block	Procedure: erector spinae plane block; o ESP Group (ŋ=25): Patients will receive ultrasound guided Erector spinae plane block with 20 ml of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a total volume of 20 ml.) at the end of procedure, unilaterally or bilaterally according to the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of total 24 hour pethidine consumption (mg) .	to measure total 24 hour pethidine consumption postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS) at rest and movement.	recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours. The Visual Analogue Scale (VAS) measures pain intensity. The visual analogue scale (VAS) consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).	24 hours postoperatively
mean arterial blood pressure (MAP)	recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours	24 hours postoperatively
heart rate (HR)	recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours	24 hours postoperatively
incidence of postoperative complications (nausea and vomiting)	recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours	24 hours postoperatively
time to start mobilization	recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MD80/2023

Drug and device information, study documents

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