A comparative study of the effect of general anesthesia , general anesthesia/ epidural analgesia on pain intensity and common complications after laparoscopic cholecystectomy
Determination and comparison of pain intensity and common complications after laparoscopic cholecystectomy surgery in patients under general anesthesia with patients receiving general anesthesia with epidural anesthesia.
Design
Several 100 patients, candidates for laparoscopic cholecystectomy surgery and meeting the study entry criteria, will be included in the easy sampling method with random allocation. After obtaining written informed consent, the participants are divided into two intervention and control groups, each group containing 50 participants.
Settings and conduct
The study is conducted by the surgical team of Shahid Jalil Hospital, Yasouj University of Medical Sciences. In this study, the evaluator and data analyzer were blinded. Epidural anesthesia using the allowed amount of marcaine 0.05% and lidocaine 2% before the induction of general anesthesia in the form of injection, a single shot epidural is performed for the intervention group. To evaluate common complaints and the level of pain intensity, use the McGill questionnaire and self-administered questionnaire. The questionnaires will be completed by a blinded evaluator, in the first stage at the time of patient admission and in the second stage in the recovery room after surgery and when the patient is awake at zero, 4, 6, 12, and 24 hours.
Participants/Inclusion and exclusion criteria
The patient is a candidate for laparoscopic cholecystectomy surgery and has no underlying diseases related to surgery or a history of sensitivity to anesthetics or local anesthesia.
Intervention groups
The intervention group will receive general anesthesia with epidural analgesia, and the control group will only be under general anesthesia.
Main outcome variables
-Severity of pain
-Type of anesthesia
-Cardiopulmonary complications
-Nausea and vomiting
-Right shoulder pain
- Abdominal discomfort
- Urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200207046408N3
Registration date:2024-02-20, 1402/12/01
Registration timing:prospective
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Reza Hosseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 1813
Email address
reza.hosseinpour@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of general anesthesia , general anesthesia/ epidural analgesia on pain intensity and common complications after laparoscopic cholecystectomy
Public title
Investigating the effect of epidural analgesia with general anesthesia on pain intensity and common complications after laparoscopic cholecystectomy compared to general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A patient who is a candidate for laparoscopic cholecystectomy surgery (with symptomatic gallstones without complications, with ASA grade 1 or 2)
Willingness to participate in the study
Age between 18 and 70 years
The patient should have mental health
Exclusion criteria:
Presence of concomitant systemic disease
History of allergy to general anesthetics and epidural anesthesia
Previous history of abdominal surgery
Acute cholecystitis and acute pancreatitis
Main bile duct stone cholangitis
Having or suspecting gallbladder malignancy
Having or suspecting heart failure and severe COPD
Suffering or history of migraine
pregnancy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who are eligible to enter the study will be randomly assigned to two groups receiving general anesthesia and general anesthesia with epidural anesthesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the evaluator of pain intensity and common complications after laparoscopic cholecystectomy and the data analyzer were blinded, but the researchers were aware of the type of method used.
Placebo
Not used
Assignment
Parallel
Other design features
One strategy that has not been studied so far in laparoscopic cholecystectomy is to combine general anesthesia with a less invasive regional analgesia method. Although this method has been previously investigated in surgeries such as abdominal aortic aneurysm, open surgery for pheochromocytoma, major abdominal surgery, open surgery for gastric cancer, etc., promising results on the effectiveness of this method in reducing postoperative complications, length It has shown the duration of hospitalization and its safety. But so far, no study has investigated this combined technique in laparoscopic cholecystectomy surgery in order to verify the feasibility of this method with the greatest effect and the least complications. Therefore, in this clinical trial research, the effectiveness of this new combined method will be investigated in patients undergoing laparoscopic cholecystectomy compared to general anesthesia
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid mottahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.YUMS.REC.1402.077
Health conditions studied
1
Description of health condition studied
Pain intensity after laparoscopic cholecystectomy
ICD-10 code
K80.10
ICD-10 code description
Calculus of gallbladder with chronic cholecystitis without obstruction
Primary outcomes
1
Description
Pain intensity :Numerical rating scale of pain intensity, which is measured by asking the patient to choose a number (between 0 and 10) and based on the McGill pain intensity scale.
Timepoint
Pain intensity as the main outcome in all patients in two study groups is evaluated by McGill questionnaire at the time of admission and before surgery. Then the same evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery.
Method of measurement
McGill Pain Intensity Scale Questionnaire
Secondary outcomes
1
Description
Common complications after laparoscopic cholecystectomy :Hypotension, bradycardia, hypoxemia, headache, nausea, vomiting, right shoulder pain, abdominal discomfort related to anesthesia and pneumoperitoneum, urinary retention.
Timepoint
Evaluation is done in the recovery room after the operation (zero hour) and 4, 6, 12, 24 hours after the end of the surgery.
Method of measurement
1. Hypotension (more than 30% decrease in baseline mean arterial pressure or systolic arterial pressure less than 90 mm Hg) 2. Bradycardia (heart rate less than 50 beats per minute) 3. Hypoxemia (SpO2 less than 90) 4. Headache or not 5. Nausea and vomiting or not 6. Right shoulder pain or not 7. Abdominal discomfort or not 8. Urinary retention or not
Intervention groups
1
Description
Intervention group: The intervention group patients will receive a single shot of epidural anesthesia with 0.06 mg/kg marcaine 0.05% and 0.14 ml/kg lidocaine 2% as an injection before receiving general anesthesia. Epidural injection in T12-L1, L1-L2 in the amount of 10-15 cc is performed with a No. 18 needle. Using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium will be administered under general anesthesia.
Category
Treatment - Surgery
2
Description
Control group: Patients in the control group will only receive general anesthesia using 0.03 mg/kg midazolam, 14.26 mcg/kg microfentanyl, 0.11 mg/kg morphine, 2.86 mg/kg propofol and 0.71 mg/kg etracurium.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil Hispital
Full name of responsible person
Reza Hosseinpour
Street address
Gharani Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Fax
+98 74 3333 7001
Email
reza.hosseinpour@yums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammadtaher Rezanejad
Street address
Shahid Mottahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 917 569 3525
Fax
+98 74 3333 7251
Email
dr.aliroostapour@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Roostapour
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Gharani Blvd Shahid Jalil Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
dr.aliroostapour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Reza Hosseinpour
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3322 1813
Fax
+98 74 3322 4722
Email
reza.hosseinpour@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Roostapour
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Gharani Blvd Shahid Jalil Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
dr.aliroostapour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available