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
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 24, 2023
March 1, 2023
5 months
September 21, 2023
October 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
amount of total 24 hour pethidine consumption (mg) .
to measure total 24 hour pethidine consumption postoperatively.
24 hours postoperatively
Secondary Outcomes (5)
visual analogue scale (VAS) at rest and movement.
24 hours postoperatively
mean arterial blood pressure (MAP)
24 hours postoperatively
heart rate (HR)
24 hours postoperatively
incidence of postoperative complications (nausea and vomiting)
24 hours postoperatively
time to start mobilization
24 hours postoperatively
Study Arms (3)
external oblique intercostal plane block
ACTIVE COMPARATORerector spinae plane block
ACTIVE COMPARATORcontrol group
NO INTERVENTIONInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with American Society of Anesthesiologists physical status (ASA) I and II.
- Both sex.
- to 60 years old patients.
- upper abdominal surgeries.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
October 24, 2023
Study Start
November 1, 2023
Primary Completion
April 1, 2024
Study Completion
June 1, 2024
Last Updated
October 24, 2023
Record last verified: 2023-03