Compared With Different Method for Postcesarean Section Analgesia
Primary Purpose
Analgesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Morphine hydrochloride
Bupivacain
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- 18-50 age
- ASA II
- Fullterm singular pregnancy
Exclusion Criteria:
- Neuraxial anesthesia is contraindicated,
- Allergy to the drugs to be used in the study,
- Refused to participate in the study,
- BMI>35 kg/m2
- ASA≥3
- Diabetes
- Preeclampsia,
- Cardiovascular disease
- Chronic pain and neuropathic pain,
- Given opioids in the operation due to intraoperative pain,
- Switched to general anesthesia,
- Excessive bleeding during the operation,
- Uterine atony
- Drain placed in the area to be infiltrated,
- History of drug addiction and psychiatric illness,
- Understand Visual analog pain scale
Sites / Locations
- Atatürk üniversty medicine school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)
Group morphine ( M )
Arm Description
local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation
intrathecal injection of morphine with local anesthesic
Outcomes
Primary Outcome Measures
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Secondary Outcome Measures
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
The VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05405049
Brief Title
Compared With Different Method for Postcesarean Section Analgesia
Official Title
Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )
Detailed Description
This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)
Arm Type
Active Comparator
Arm Description
local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation
Arm Title
Group morphine ( M )
Arm Type
Active Comparator
Arm Description
intrathecal injection of morphine with local anesthesic
Intervention Type
Drug
Intervention Name(s)
Morphine hydrochloride
Other Intervention Name(s)
Bupivacaine, fentanyl
Intervention Description
Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
lidocain, fentanyl
Intervention Description
Group LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation
Primary Outcome Measure Information:
Title
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Description
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
Description
The VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain)
Time Frame
2,4,6,12,and 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women
18-50 age
ASA II
Fullterm singular pregnancy
Exclusion Criteria:
Neuraxial anesthesia is contraindicated,
Allergy to the drugs to be used in the study,
Refused to participate in the study,
BMI>35 kg/m2
ASA≥3
Diabetes
Preeclampsia,
Cardiovascular disease
Chronic pain and neuropathic pain,
Given opioids in the operation due to intraoperative pain,
Switched to general anesthesia,
Excessive bleeding during the operation,
Uterine atony
Drain placed in the area to be infiltrated,
History of drug addiction and psychiatric illness,
Understand Visual analog pain scale
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nazım doğan, prof
Phone
905336365805
Email
nazdogan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mehmet aksoy, doc
Phone
905058193526
Email
drmaksoy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayşenur dostbil, prof
Organizational Affiliation
Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk üniversty medicine school
City
Erzurum
State/Province
Yakuti̇ye
ZIP/Postal Code
25100
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysenur Dostbil
Phone
05333676696
Email
adostbil@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Compared With Different Method for Postcesarean Section Analgesia
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