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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
segmental spinal anesthesia
Sponsored by
Avicenna Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gall Stones (& [Calculus - Gall Bladder])

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    segmental spinal anesthesia

    Arm Description

    thoracic spinal anesthesia at T 10 level

    Outcomes

    Primary Outcome Measures

    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)
    Hemodynamic tolerance of segmental spinal anesthesia.
    Heart rate (beats per minute): monitored and recorded every 5 minutes:
    Hemodynamic tolerance of segmental spinal anesthesia.
    Non-invasive blood pressure (mmHg): monitored and recorded every 5 minutes:
    Respiratory safety of segmental spinal anesthesia.
    Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.
    Respiratory safety of segmental spinal anesthesia.
    Pulse oximetry (%): monitored and recorded every 5 minutes.

    Secondary Outcome Measures

    surgeon's satisfaction with anesthesia technique
    numeric scale from 0 to 10 (0: worst surgical conditions, 10: best operative conditions)
    patient satisfaction with anesthesia technique
    numeric rating scale from 0 to 10
    postoperative adverse effects
    nausea and vomiting, urinary retention, pruritus, headache, neurologic symptoms

    Full Information

    First Posted
    August 10, 2017
    Last Updated
    November 13, 2022
    Sponsor
    Avicenna Military Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05165641
    Brief Title
    Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital
    Acronym
    SPICHOL
    Official Title
    Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Avicenna Military Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gall Stones (& [Calculus - Gall Bladder]), Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    segmental spinal anesthesia
    Arm Type
    Other
    Arm Description
    thoracic spinal anesthesia at T 10 level
    Intervention Type
    Procedure
    Intervention Name(s)
    segmental spinal anesthesia
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital
    Description
    Patients' peroperative pain scores assessed on a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain)
    Time Frame
    intraoperatively
    Title
    Hemodynamic tolerance of segmental spinal anesthesia.
    Description
    Heart rate (beats per minute): monitored and recorded every 5 minutes:
    Time Frame
    intraoperatively
    Title
    Hemodynamic tolerance of segmental spinal anesthesia.
    Description
    Non-invasive blood pressure (mmHg): monitored and recorded every 5 minutes:
    Time Frame
    intraoperatively
    Title
    Respiratory safety of segmental spinal anesthesia.
    Description
    Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.
    Time Frame
    intraoperatively
    Title
    Respiratory safety of segmental spinal anesthesia.
    Description
    Pulse oximetry (%): monitored and recorded every 5 minutes.
    Time Frame
    intraoperatively
    Secondary Outcome Measure Information:
    Title
    surgeon's satisfaction with anesthesia technique
    Description
    numeric scale from 0 to 10 (0: worst surgical conditions, 10: best operative conditions)
    Time Frame
    intraoperatively
    Title
    patient satisfaction with anesthesia technique
    Description
    numeric rating scale from 0 to 10
    Time Frame
    24 hours postoperatively
    Title
    postoperative adverse effects
    Description
    nausea and vomiting, urinary retention, pruritus, headache, neurologic symptoms
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: uncomplicated symptomatic cholelithiasis American society of anesthesiologists (ASA) physical status I, II, or III Exclusion Criteria: patients with acute cholecystitis suspected common bile duct stones previous abdominal surgery bleeding diathesis spinal abnormality allergy to any drug used in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Younes Aissaoui
    Organizational Affiliation
    Avicenna Military Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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