ClinicalTrials.gg
CompletedNCT05165641SPICHOLUpdated Nov 15, 2022

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

An interventional study of segmental spinal anesthesia in Gall Stones (& [Calculus - Gall Bladder]) and Anesthesia, sponsored by Avicenna Military Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Avicenna Military Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Feb 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's enrollment of 62 is below the median of 98 across 121 interventional studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Avicenna Military Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • uncomplicated symptomatic cholelithiasis
  • (ASA) physical status I, II, or III

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Other
    segmental spinal anesthesia

    thoracic spinal anesthesia at T 10 level

    Procedure: segmental spinal anesthesia

Interventions

  • Proceduresegmental spinal anesthesia

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: intraoperatively

  2. Hemodynamic tolerance of segmental spinal anesthesia.

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

    Time frame: intraoperatively

  3. Hemodynamic tolerance of segmental spinal anesthesia.

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

    Time frame: intraoperatively

  4. Respiratory safety of segmental spinal anesthesia.

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

    Time frame: intraoperatively

  5. Respiratory safety of segmental spinal anesthesia.

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

    Time frame: intraoperatively

Secondary outcomes

  1. surgeon's satisfaction with anesthesia technique

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

    Time frame: intraoperatively

  2. patient satisfaction with anesthesia technique

    numeric rating scale from 0 to 10

    Time frame: 24 hours postoperatively

  3. postoperative adverse effects

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

    Time frame: 24 hours postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Mar 2017, 13 months.

Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 13 months is below that.

Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2017
First posted
Dec 21, 2021
StartActual
Feb 1, 2016
Primary completionActual
Mar 31, 2017
CompletionActual
Mar 31, 2017
Last update
Nov 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05165641
Lead sponsor
Avicenna Military Hospital
Responsible party
Younes Aissaoui, MD (Professor of anesthesia and intensive care medicine, Avicenna Military Hospital) — Principal investigator
First posted
Dec 21, 2021
Start date
Feb 1, 2016
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Nov 15, 2022

Study contacts

Younes Aissaoui
principal investigator · Avicenna Military Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion