Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital

NCT05165641 | Completed DMC

• 1 other identifier: SPICHOL AvicennaMH
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Providing safe and efficient anesthesia and in a field hospital is a challenging situation. This study investigated the feasibility and safety of thoracic spinal anesthesia for small-incision open cholecystectomy in a deployed field hospital.

Conditions

Gall Stones (& [Calculus - Gall Bladder]); Anesthesia

Outcome Measures

Primary Outcomes (5)

• Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital

  Patients' peroperative pain scores assessed on a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain)

  intraoperatively

• Hemodynamic tolerance of segmental spinal anesthesia.

  Heart rate (beats per minute): monitored and recorded every 5 minutes:

  intraoperatively

• Hemodynamic tolerance of segmental spinal anesthesia.

  Non-invasive blood pressure (mmHg): monitored and recorded every 5 minutes:

  intraoperatively

• Respiratory safety of segmental spinal anesthesia.

  Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.

  intraoperatively

• Respiratory safety of segmental spinal anesthesia.

  Pulse oximetry (%): monitored and recorded every 5 minutes.

  intraoperatively

Secondary Outcomes (3)

• surgeon's satisfaction with anesthesia technique

  intraoperatively

• patient satisfaction with anesthesia technique

  24 hours postoperatively

• postoperative adverse effects

  24 hours postoperatively

Study Arms (1)

segmental spinal anesthesia

OTHER

thoracic spinal anesthesia at T 10 level

Procedure: segmental spinal anesthesia

Interventions

segmental spinal anesthesia PROCEDURE

Spinal anesthesia was performed at a lower thoracic level with the patient in the sitting position. After local anesthesia with 1% lidocaine, the spinal puncture was done in the 10th thoracic intervertebral space (T 10) through a median approach. A 27 Gg pencil-point needle with an introducer was used (marquee). To identify T 10, the vertebra prominens (C7) was palpated and the spinous processes were palpated caudally \[ref}. Two senior anesthesiologists performed all the spinal punctures. The progression of the spinal needle was cautious and soft. The effort was made to stop the needle progression just after the tactile perception of the dura mater. Once the flow of cerebrospinal fluid was obtained, 1.5 ml of hyperbaric bupivacaine 5mg/ml (=7.5 mg) mixed with 0.5 ml of fentanyl 50 µg/ml (= 25 µg) was injected and the spinal needle removed.

segmental spinal anesthesia

Eligibility Criteria

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

You may qualify if:

• uncomplicated symptomatic cholelithiasis
• American society of anesthesiologists (ASA) physical status I, II, or III

You may not qualify if:

• patients with acute cholecystitis
• suspected common bile duct stones
• previous abdominal surgery
• bleeding diathesis
• spinal abnormality
• allergy to any drug used in the study

Sponsors & Collaborators

• Avicenna Military Hospital: lead

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Younes Aissaoui

  Avicenna Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care medicine

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: December 21, 2021
• Study Start: February 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share