Paravertebral Block vs. General Anesthesia for Major Abdominal Surgery

NCT02534012 | Unknown

• 1 other identifier: 182015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Hence, elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic technique.

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Number of patients admitted to Intensive Care Unit (ICU)

  48 hours postoperatively

Secondary Outcomes (2)

• Hemodynamic stability measured through Mean Arterial Pressure (mmHg)

  48 hours postoperatively

• Hemodynamic stability measured through heart rate (beats per minute)

  48 hours postoperatively

Other Outcomes (1)

• Number of patients who passed away

  48 hours postoperatively

Study Arms (2)

PVB group

EXPERIMENTAL

Patients will receive nerve stimulator guided paravertebral block

Drug: Paravertebral block; Procedure: Major abdominal surgery

GA group

EXPERIMENTAL

Patients will receive general anesthesia

Drug: General anesthesia; Procedure: Major abdominal surgery

Interventions

Paravertebral block DRUG

Bilateral nerve stimulator-guided PVB is performed while patients are in lateral decubitis position. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline on both sides. After aseptic preparation of the skin, 0.3 mL 2% lidocaine is infiltrated at the injection sites. A 22-G nerve stimulation needle (Stimuplex, B.Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to continue to produce muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA. Depending on patient weight, 3-5 mL of the local anaesthetic mixture is injected at each injection site.

PVB group

General anesthesia DRUG

Anesthesia is induced with 1 µg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg nimbex (cisatracurium). Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 µg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen.

GA group

Major abdominal surgery PROCEDURE

GA group; PVB group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 70 years or older admitted for major abdominal surgery

You may not qualify if:

• Known history of allergic reactions to local anesthesia
• Neurological disorders
• Bleeding disorders
• Infection at site of injection.

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Zoher Naja, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoher Naja, MD

CONTACT

+9611636000; zouhnaja@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 27, 2015
• Study Start: May 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)