NCT06097286

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 24, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

September 21, 2023

Last Update Submit

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 COMPARATOR
Procedure: external oblique intercostal plane block

erector spinae plane block

ACTIVE COMPARATOR
Procedure: erector spinae plane block

control group

NO INTERVENTION

Interventions

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.

external oblique intercostal 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.

erector spinae plane block

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

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