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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
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
May 24, 2022
Last Updated
June 2, 2022
Sponsor
Ataturk University
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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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