Gall Stones (& [Calculus - Gall Bladder])SPICHOLNCT05165641
Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital
A study testing segmental spinal anesthesia in people with Gall Stones (& [Calculus - Gall Bladder]) and Anesthesia, run by Avicenna Military Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gall Stones (& [Calculus - Gall Bladder]), Anesthesia
- What is being tested?
- segmental spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated symptomatic cholelithiasis
- American society of anesthesiologists (ASA) physical status I, II, or III
Who cannot join
- patients with acute cholecystitis
- suspected common bile duct stones
- previous abdominal surgery
- bleeding diathesis
- spinal abnormality
- allergy to any drug used in the study
About this study
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.
- Being tested
- segmental spinal anesthesia
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental spinal anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| segmental spinal anesthesia | Other | thoracic spinal anesthesia at T 10 level Receives: Procedure: segmental spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: intraoperatively
Hemodynamic tolerance of segmental spinal anesthesia.
Heart rate (beats per minute): monitored and recorded every 5 minutes:
Measured: intraoperatively
Hemodynamic tolerance of segmental spinal anesthesia.
Non-invasive blood pressure (mmHg): monitored and recorded every 5 minutes:
Measured: intraoperatively
Respiratory safety of segmental spinal anesthesia.
Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.
Measured: intraoperatively
Respiratory safety of segmental spinal anesthesia.
Pulse oximetry (%): monitored and recorded every 5 minutes.
Measured: intraoperatively
Secondary outcomes (3)
surgeon's satisfaction with anesthesia technique
numeric scale from 0 to 10 (0: worst surgical conditions, 10: best operative conditions)
Measured: intraoperatively
patient satisfaction with anesthesia technique
numeric rating scale from 0 to 10
Measured: 24 hours postoperatively
postoperative adverse effects
nausea and vomiting, urinary retention, pruritus, headache, neurologic symptoms
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Feb 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Stones (& [Calculus - Gall Bladder])Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avicenna Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Aissaoui, MD, Avicenna Military Hospital
- Investigators
- Younes Aissaoui, Principal investigator, Avicenna Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165641
- Sponsor's protocol ID
- SPICHOL AvicennaMH
- Acronym
- SPICHOL
- Status last verified
- Nov 2022
- First submitted
- 10 Aug 2017
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Spinal Anesthesia for Small-incision Cholecystectomy in a Field Hospital
- ClinicalTrials.gov ID
- NCT05165641
- Acronym / sponsor ID
- SPICHOL / SPICHOL AvicennaMH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Avicenna Military HospitalUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| segmental spinal anesthesia | Other | Procedure: segmental spinal anesthesiathoracic spinal anesthesia at T 10 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- uncomplicated symptomatic cholelithiasis
- American society of anesthesiologists (ASA) physical status I, II, or III
Key exclusion criteria (6 listed)
- patients with acute cholecystitis
- suspected common bile duct stones
- previous abdominal surgery
- bleeding diathesis
- spinal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| segmental spinal anesthesiaSpinal 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. | Procedure or surgery | segmental spinal anesthesia |
Primary outcome
Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital
Time frame: intraoperatively
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.
Time frame: intraoperatively
Heart rate (beats per minute): monitored and recorded every 5 minutes:
Hemodynamic tolerance of segmental spinal anesthesia.
Time frame: intraoperatively
Non-invasive blood pressure (mmHg): monitored and recorded every 5 minutes:
Respiratory safety of segmental spinal anesthesia.
Time frame: intraoperatively
Respiratory rate (breaths per minute): monitored and recorded every 5 minutes.
Respiratory safety of segmental spinal anesthesia.
Time frame: intraoperatively
Pulse oximetry (%): monitored and recorded every 5 minutes.
3 secondary outcomes
surgeon's satisfaction with anesthesia technique
Time frame: intraoperatively
patient satisfaction with anesthesia technique
Time frame: 24 hours postoperatively
postoperative adverse effects
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Gall Stones (& [Calculus - Gall Bladder])
Enrolling by invitation
A Study on the Efficacy and Safety of Endoscopic Ultrasound-guided Gastro-/Duodeno-cholecystostomy for the Treatment of Gallstones.
Gall Stones, Gall Stones (& [Calculus - Gall Bladder])
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Younes Aissaoui principal investigator
Avicenna Military Hospital
Questions about this trial
What is this clinical trial studying?
A study testing segmental spinal anesthesia in people with Gall Stones (& [Calculus - Gall Bladder]) and Anesthesia, run by Avicenna Military Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of segmental spinal anesthesia for small-incision open cholecystectomy in a field hospital (time frame: intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022; AzTrials last refreshed its copy on 3 Nov 2026.