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
October 22, 2023 updated by: Ain Shams University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
75
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Active Comparator: 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
|
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) .
Time Frame: 24 hours postoperatively
|
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.
Time Frame: 24 hours postoperatively
|
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)
Time Frame: 24 hours postoperatively
|
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
|
24 hours postoperatively
|
|
heart rate (HR)
Time Frame: 24 hours postoperatively
|
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
|
24 hours postoperatively
|
|
incidence of postoperative complications (nausea and vomiting)
Time Frame: 24 hours postoperatively
|
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
|
24 hours postoperatively
|
|
time to start mobilization
Time Frame: 24 hours postoperatively
|
recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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