The effect of patient-controlled analgesia versus intrathecal opioid injection on patient satisfaction with pain control after cesarean section
Design
Phase III randomized trial with parallel groups on 60 patients, randomization with a randomization table by the Random Allocation software
Settings and conduct
This study will be performed on 60 candidates for elective cesarean section referred to Khalij Fars and Shariati Hospitals, Bandar Abbas. Patients will be randomized into two groups based on a randomization table. In the 1st intervention group, 3 ml spinal anesthesia solution containing 12 mg bupivacaine 0.5% and 20 mg pethidine will be injected intathecally. In the 2nd intervention group normal saline with the same amount of pethidine will be included in the solution. Also, a patient-controlled analgesia (PCA) pump containing morphine at 1 mg/h will be set up in the recovery for these patients. Patient satisfaction with pain control will be assessed after gaining consciousness in the recovery and then at 1, 4, and 24 hours in the ward, using a numerical rating scale (NRS). Also, pruritus, nausea and/or vomiting, and respiratory depression will be assessed up to 24 hours after surgery. Given the nature of the interventions blinding will not be possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnancy; elective cesarean section; ASA class I and II; age of 18-46 years.
Exclusion criteria: emergency cesarean section; intraoperative complication of cesarean section.
Intervention groups
Intervention 1: 3 ml spinal anesthesia solution containing 12 mg bupivacaine 0.5% and 20 mg pethidine injected intathecally.
Intervention 2: 3 ml spinal anesthesia solution containing 12 mg bupivacaine 0.5% and normal saline injected intathecally. Also, a PCA pump of morphine at 1 mg/h will be set up in the recovery.
Main outcome variables
Patient satisfaction with pain control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054492N1
Registration date:2022-07-25, 1401/05/03
Registration timing:retrospective
Last update:2022-07-25, 1401/05/03
Update count:0
Registration date
2022-07-25, 1401/05/03
Registrant information
Name
Abbas Moallemy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0370
Email address
moallemyaln@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-01, 1395/12/11
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
2017-03-01, 1395/12/11
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
2018-02-01, 1396/11/12
Scientific title
Effect of patient-controlled analgesia versus intrathecal opioid injection on patient satisfaction with pain control after cesarean section
Public title
Patient-controlled analgesia versus intrathecal opioid for pain after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
Elective cesarean section
ASA class I and II
Age: 18-46 years old
Exclusion criteria:
Emergency cesarean section
Complications during cesarean section
Age
From 18 years old to 46 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. Allocation concealment will be done using unclear envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.HUMS.REC.1395.135
Health conditions studied
1
Description of health condition studied
Post-cesarean section pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Patient satisfaction with analgesia
Timepoint
After gaining consciousness in the recovery and then at 1, 4, and 24 hours in the ward
Method of measurement
Numerical rating scale (NRS)
Secondary outcomes
1
Description
Drug side effects
Timepoint
Up to 24 hours after surgery
Method of measurement
Pruritus, nausea and/or vomiting, and respiratory depression (respiratory rate <10/min)
Intervention groups
1
Description
Intervention group 1: 3 ml spinal anesthesia solution containing 12 mg bupivacaine 0.5% (MYLAN S.A.S, France) and 20 mg pethidine (Exir Pharmaceutical Co., Iran) injected intathecally.
Category
Prevention
2
Description
Intervention 2: 3 ml spinal anesthesia solution containing 12 mg bupivacaine 0.5% (MYLAN S.A.S, France) and normal saline injected intathecally. Also, a PCA pump of morphine (Iran Tajhiz Co., Iran) at 1 mg/h will be set up in the recovery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital, Bandar Abbas
Full name of responsible person
Abbas Moallemy
Street address
Dr. Ali Shariati Hospital, Shahid Naser Blvd., Next to the Revolutionary Court, Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 5934
Email
moallemyaln@yahoo.com
Web page address
https://dshh.hums.ac.ir/
2
Recruitment center
Name of recruitment center
Khalij Fars Hospital, Bandar Abbas
Full name of responsible person
Abbas Moallemy
Street address
Khalij Fars Hospital, Azad University Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0280
Email
moallemyaln@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Imam Hossein Blvd., across from Kargaran Sports Complex
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abbas Moallemy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
moallymialn@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abbas Moallemy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
979199155
Phone
+98 76 3334 5009
Email
moallemyaln@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abbas Moallemy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
979199155
Phone
+98 76 3334 5009
Email
moallemyaln@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD