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

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06097286
Collaborator
(none)
75
3
7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: external oblique intercostal plane block
  • Procedure: erector spinae plane block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. amount of total 24 hour pethidine consumption (mg) . [24 hours postoperatively]

    to measure total 24 hour pethidine consumption postoperatively.

Secondary Outcome Measures

  1. visual analogue scale (VAS) at rest and movement. [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).

  2. mean arterial blood pressure (MAP) [24 hours postoperatively]

    recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours

  3. heart rate (HR) [24 hours postoperatively]

    recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours

  4. incidence of postoperative complications (nausea and vomiting) [24 hours postoperatively]

    recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours

  5. time to start mobilization [24 hours postoperatively]

    recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT06097286
Other Study ID Numbers:
  • MD80/2023
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 24, 2023