Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Emergency Abdominal Surgery with Midline Incision

NCT06448299 | Completed

• 1 other identifier: MD-305-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Most of the recommendations regarding pain management in emergency abdominal surgery are extracted from data from elective abdominal surgery. However, surgery in the emergency settings differs from the elective settings in the extent stress and the pain which is usually present preoperatively; therefore, it is expected to have different analgesic requirements and different response to pain management interventions in emergency surgery. Abdominal wall blocks are increasingly used in abdominal surgery. However, data regarding their efficacy in emergency setting are lacking. Oblique-subcostal transversus abdominis plane block (OS-TAPB) is a variation of the subcostal TAPB that could achieve effective analgesia for both upper and lower parts of the abdomen. The TAPB characterized by being easy to perform and does not require patient repositioning. Erector spinae plane block (ESPB) is another abdominal wall block that showed good analgesic effect following various elective open abdominal surgeries, but the block requires patient repositioning before block performance. In elective abdominal surgeries, the current evidence slightly supports ESPB over the TAPB. We hypothesize that the difference between the two blocks would be more apparent in in emergency surgery due to the type of incision, extent of tissue manipulation, and severity of pain.

Conditions

Pain, Postoperative; Abdominal Surgery; Emergency

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption

  mg

  30 minutes postoperatively till 24 hours postoperatively

Secondary Outcomes (6)

• numerical rating scale at rest

  30 minutes postoperatively till 24 hours postoperatively

• numerical rating scale during cough

  30 minutes postoperatively till 24 hours postoperatively

• Time to first morphine requirement

  30 minutes postoperatively till 24 hours postoperatively

• Time to independent movement

  30 minutes postoperatively till 24 hours postoperatively

• postoperative sedation

  30 minutes postoperatively till 24 hours postoperatively

Study Arms (2)

TAPB

ACTIVE COMPARATOR

Procedure: TAPB

ESPB

ACTIVE COMPARATOR

Biological: ESPB

Interventions

TAPB PROCEDURE

Patients will receive ultrasound guided bilateral oblique subcostal TAPB using 25 mL bupivacaine 0.25% in each side

TAPB

ESPB BIOLOGICAL

Patients will receive ultrasound guided bilateral ESPB at T8 level using 25 mL bupivacaine 0.25% in each side

ESPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (\>18 years), undergoing emergency abdominal surgery with midline incision

You may not qualify if:

• American society of anesthesiologist-physical status \>III,
• patients with a history of allergy to any of the study drugs,
• a body mass index (BMI) \<18 or ≥ 40 kg/m2,
• coagulopathy
• local infection,
• history of chronic pain or regular opioid use;
• inability to comprehend the Numeric Rating Scale (NRS),
• pregnant or lactating women. Patients on vasopressor infusion,
• patients with high shock index (heart rate / systolic blood pressure \>1)
• patients requiring postoperative mechanical ventilation will be excluded from the study.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Emergencies

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 20, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 8, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)