Comparison of the role of intrapleural pethidine injection with intravenous morphine in the management of post-operative pain after open cholesystectomy
Comparison of the role of intrapleural pethidine injection with intravenous morphine in the management of post-operative pain after open cholesystectomy
Design
Randomized,controlled clinical trial, phase 3, with two arm parallel groups with blind patients, documentation and outcome assessment, sample volume of 80 patients divided into 2 groups of 40 patients
Settings and conduct
In the operating room of Loghman Hakim hospital, at the end of the surgery, in the intervention group, the neuromuscular reversal agents is administered and the infusion of propofol and remifental continues.A metallic epidural needle is inserted in the right fifth intercostal space at the midaxillary line.The correct placement of the needle within the intrapleural space is checked confirmed by the suction of water drop into the space( hanging-drop technique).The total volume of 20 milliliter of the drug is injected, which is normal saline in the control group.In this group 0.1 milligram per kilogram of body weight of morphine sulfate is injected intravenously.
The injected drug in the intervention group is 50 milligram of Pethidine diluted in saline.
Participants/Inclusion and exclusion criteria
Candidates for elective open cholecystectomy;with ASA Class=1 or 2; No previous history of addiction or prolonged analgesic consumption; No history of thoracotomy
Intervention groups
Intervention group: as the postoperative management regimen, interpleural block(Hanging drop technique) by pethidine is planned; Control group: to control the postoperative pain, intravenous morphine is prescribed.For blinding, interpleural block is performed by the same volume of normal saline.
Main outcome variables
Amount of consumed morphine during the first 12 hours of postoperative period; The time of first demand for morphine during the postoperative period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151012024493N3
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Parissa Sezari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 219 4036
Email address
psezari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Comparison of the role of intrapleural pethidine injection with intravenous morphine in the management of post-operative pain after open cholesystectomy
Public title
Comparison of the role of intrapleural pethidine injection with intravenous morphine in the management of post-operative pain after open cholesystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective open cholecystectomy surgery
ASA class = 1 or 2
BMI between 18 to 30 kg/m2
Exclusion criteria:
History of addiction
History of prolonged analgesic consumption
History of thoractomy
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelope method: The assigned group is written on a paper within sequentially numbered, opaque, sealed envelopes. Investigators should only open the envelopes sequentially, right before the beginning of anesthesia for each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients are not aware of the type of the applied technique.
The chief researcher who is responsible for patient's safety and preparing the drugs, is aware of the techniques administered. But the resident and the nurse in the recovery ward do not know which technique has been used.
The coding of the groups are numerical and the statistical analyst and the laboratory personnel are not aware of the coding type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor in research Affairs-Shahid Beheshti university of medical sciences
Amount of consumed morphine during the first 12 hours of postoperative period
Timepoint
12 hours after surgery
Method of measurement
Documented total amount of injected morphine in milligrams
2
Description
The time of first demand for morphine during the postoperative period
Timepoint
The time of first patient's demand for morphine during the postoperative period in minutes
Method of measurement
chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: At the end of the surgery,the patient receives the neuromuscular reversal agents and the infusion of propofol and remifental continues.A metallic epidural needle is inserted in the right fifth intercostal space at the midaxillary line.The correct placement of the needle within the intrapleural space is checked confirmed by the suction of water drop into the space( hanging-drop technique).The total volume of 20 milliliter of the drug is injected, which is normal saline in the control group.In this group 0.1 milligram per kilogram of body weight of morphine sulfate is injected intravenously.
Category
Treatment - Other
2
Description
Intervention group: At the end of the surgery,the patient receives the neuromuscular reversal agents and the infusion of propofol and remifental continues.A metallic epidural needle is inserted in the right fifth intercostal space at the midaxillary line.The correct placement of the needle within the intrapleural space is checked confirmed by the suction of water drop into the space( hanging-drop technique).The total volume of 20 milliliter of the drug is injected, which in the intervention group is 50 milligram of Pethidine diluted in saline.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Parisa Sezari
Street address
Loghman Hakim hospital, Makhsus St., South Kargar Ave., Tehran