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

Erector Spinae Plane Block Versus Oblique-Subcostal Transversus Abdominis Plane Block in Patients Undergoing Emergency Abdominal Surgery with Midline Incision: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Abdominal Surgery; Emergency
• Intervention / Treatment: Procedure: TAPB; Biological: ESPB

Detailed Description

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg and omeprazole 40 mg).

General anesthesia will be induced by 2 mg/kg propofol and 1 mcg/kg fentanyl. After loss of consciousness, tracheal intubation by direct laryngoscopy will be facilitated by 1 mg/kg succinyl choline. Anesthesia will be maintained by 1-1.2% isoflurane and atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg. Atracurium increments of 0.1 mg/kg will be administered every 20 min for maintenance of neuromuscular blockade.

After induction of anesthesia, patients will receive the block according to the group assignment In both blocks a total of 25 mL of 0.25% bupivacaine will be administered in each side.

The blocks will be performed by an experienced operator who will be informed of the patient group after induction of anesthesia. The patient, surgeon and data collector will be blinded to the study group.

Intraoperative analgesic management Fentanyl boluses of 1 mcg/kg will be given in case of inadequate analgesia (heart rate/mean blood pressure increase by 20% from the baseline in absence of other causes) Intraoperative fluid and hemodynamic management will be according to the discretion of the attending anesthetist.

At the end of the surgery, all patients will receive intravenous acetaminophen (1 g) before the extubation.

Postoperative care All patients will receive regular intravenous acetaminophen 1 g/6 hours. Pain assessments using NRS will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room. If NRS score is > 3 (at any time not limited to the time of assessment) intravenous titration of 3 mg morphine is given slowly to be repeated after 30 minutes if pain persisted. If other opioids are given, morphine equivalent dose will be calculated using opioids conversion chart.

Intravenous ondansetron 4 mg will be given to treat nausea or vomiting if occurs

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESPB	Biological: ESPB; Patients will receive ultrasound guided bilateral ESPB at T8 level using 25 mL bupivacaine 0.25% in each side
Active Comparator: TAPB	Procedure: TAPB; Patients will receive ultrasound guided bilateral oblique subcostal TAPB using 25 mL bupivacaine 0.25% in each side

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morphine consumption	mg	30 minutes postoperatively till 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale at rest	11-points scale in which the patients are asked to circle the number between 0 and 10 that best describe their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible) will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room	30 minutes postoperatively till 24 hours postoperatively
numerical rating scale during cough	11-points scale in which the patients are asked to circle the number between 0 and 10 that best describe their pain intensity. Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible) will be performed at rest and during cough at 0.5, 1, 4, 8, 12, 24 h after leaving the operating room	30 minutes postoperatively till 24 hours postoperatively
Time to first morphine requirement	hours	30 minutes postoperatively till 24 hours postoperatively
Time to independent movement	hours	30 minutes postoperatively till 24 hours postoperatively
postoperative sedation	modified Ramsay Sedation score	30 minutes postoperatively till 24 hours postoperatively
patients satisfaction	using the NRS 0= worst experience, 10= best experience.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Disease Attributes; Pain, Postoperative; Emergencies
• Other Study ID Numbers: MD-305-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data related to this study will be provided from the PI upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No