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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06097286
Other study ID # MD80/2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date June 1, 2024

Study information

Verified date March 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date June 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
external oblique intercostal plane block
o EOIP Group (?=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.
erector spinae plane block
o ESP Group (?=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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary amount of total 24 hour pethidine consumption (mg) . to measure total 24 hour pethidine consumption postoperatively. 24 hours postoperatively
Secondary 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
Secondary mean arterial blood pressure (MAP) recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours 24 hours postoperatively
Secondary heart rate (HR) recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours 24 hours postoperatively
Secondary incidence of postoperative complications (nausea and vomiting) recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours 24 hours postoperatively
Secondary time to start mobilization recorded postoperative immediately and 2, 4, 6, 8, 12, 18 and 24 hours 24 hours postoperatively
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