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.

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

Gall Stones (& [Calculus - Gall Bladder])

Anesthesia

This study was conducted in a field hospital deployed in a rural area of the middle Atlas in
      Morocco during the winters of 2016 and 2017. The Middle Atlas is a part of the Atlas mountain
      range which is usually blocked and isolated by snow during the winter. The hospital deployed
      was an inflatable tent hospital self-contained and self-sufficient. This field hospital
      included the following components: a patient's ward (sixty beds), an operating theater with
      one surgical table, a recovery room with 2 beds, a laboratory, an X-ray unit, a pharmacy, and
      several exams rooms.

      After approval by the Ethical review board of Avicenna Military Hospital, Marrakech, Morocco
      (CERB7/2016), written informed consent was obtained from patients who agreed to participate
      in the study.

      The inclusion criteria were: uncomplicated symptomatic cholelithiasis confirmed by
      preoperative ultrasound, age 18 years or older and American society of anesthesiologists
      (ASA) physical status I, II or III. Exclusion criteria were: patients with acute
      cholecystitis, suspected common bile duct stones, previous abdominal surgery, bleeding
      diathesis, spinal abnormality, and allergy to any drug used in the study.

      Patients were interviewed and examined by an anesthesiologist in a preoperative visit several
      days before surgery. On arrival in the operating room the patient's non-invasive blood
      pressure, oxygen saturation, and heart rate were monitored. Heart rate and blood pressure
      were recorded every five minutes. Intravenous access was established in the forearm with an
      18 Gauge catheter and patients received a preload with 10 ml/Kg of normal saline. Patients
      were given 1mg midazolam intravenously for anxiolysis and oxygen 2-3 l /min was administered
      by a nasal cannula. Cefazolin 2 g was injected as antimicrobial prophylaxis. Antiemetic
      prophylaxis was also carried out with dexamethasone 4 mg IV.

      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. 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. Patients were asked to report any pain or paresthesia during
      the puncture. The patient was then placed in a supine horizontal position. The level of
      sensory block was assessed every 2 minutes (pinprick method). After an adequate sensory block
      was obtained (T4 - T 12), surgery was allowed to start. The nasogastric tube was not inserted
      unless the surgeon required it.

      Patients were invited to report any discomfort or pain during surgery. Patients were asked to
      assess any eventual pain on a numeric rating scale ranging from 0 (no pain) to 10 (worst
      possible pain). Perioperative pain scores were collected at skin incision and perioperative
      pain and anxiety were treated with boluses of fentanyl 50 µg (maximum 100 µg) and midazolam 1
      mg (maximum 5 mg). The need for additional sedation/analgesia and the doses administered were
      recorded. Patients were informed about the possibility of switching to general anesthesia
      (GA). Criteria for conversion to GA were: failure of spinal anesthesia, pain score > 4
      despite a maximum dose of fentanyl, and difficult surgical conditions.

      Two experienced surgeons performed all operations. Small incision open cholecystectomy was
      performed with a 6 to 8 cm long transverse incision over the right rectus abdominis muscle,
      as described by Rosenmuller [ref]. Surgeon s satisfaction was evaluated by asking surgeons to
      assess the operative conditions on a numeric scale of 0 to 10 (0: worst surgical conditions,
      10: best operative conditions). At the time of skin closure, a wound infiltration (muscular
      compartment and subcutaneous fat) with 15 to 20ml of bupivacaine 0.25% was made.

      The duration of surgery and perioperative incidents (hypotension, bradycardia nausea, and/or
      vomiting) were recorded. Hypotension defined as a drop in the mean arterial blood pressure
      (MAP) ≥20% below baseline was managed by IV boluses of ephedrine 6 mg. Bradycardia was
      defined as heart rate <50 and treated with atropine 0.50 mg. Post-operative events were also
      recorded: nausea and vomiting, urinary retention, pruritus, headache, or neurologic symptom.
      Patients were discharged the day after the surgery.

segmental spinal anesthesia

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

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

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

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

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

Professor of anesthesia and intensive care medicine

numeric scale from 0 to 10 (0: worst surgical conditions, 10: best operative conditions)

nausea and vomiting, urinary retention, pruritus, headache, neurologic symptoms

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?