Back to resultsComparison of the Quality of Recovery After Cesarean Section Surgery
Primary Purpose
Postoperative Recovery, Abdominal Pain, Cesarean Section
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversalis Fascia Plane Block
Transversus Abdominis Plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Recovery focused on measuring cesarean section surgery, postoperative recovery, postoperative pain, trasversalis fascia plane block, transversus abdominis plane block, obstetric quality of recovery 11 Turkish score, numeric rating scale
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status II-III Cesarean section surgery under spinal anesthesia Exclusion Criteria: American Society of Anesthesiologists physical status IV Emergency surgery General anesthesia Additional surgical intervention at the same session Body mass index of more than 35 kg/m2 Allergy to any study drugs Local infection at the injection site History of drug abuse Communication problem Coagulopathy Preeclampsia and eclampsia
Sites / Locations
- Mugla Sıtkı Kocman University Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transversalis Fascia Plane Block (TFPB) Group
Transversus Abdominis Plane (TAP) Block Group
Arm Description
At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.
At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.
Outcomes
Primary Outcome Measures
Postoperative quality of recovery
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
Secondary Outcome Measures
Postoperative opioid consumption
Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Numeric Rating Scale
A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Adverse Reactions
Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed
Full Information
NCT ID
NCT05999981
First Posted
August 14, 2023
Last Updated
August 18, 2023
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT05999981
Brief Title
Comparison of the Quality of Recovery After Cesarean Section Surgery
Official Title
Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 24, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman 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
Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Recovery, Abdominal Pain, Cesarean Section
Keywords
cesarean section surgery, postoperative recovery, postoperative pain, trasversalis fascia plane block, transversus abdominis plane block, obstetric quality of recovery 11 Turkish score, numeric rating scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transversalis Fascia Plane Block (TFPB) Group
Arm Type
Active Comparator
Arm Description
At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally.
Arm Title
Transversus Abdominis Plane (TAP) Block Group
Arm Type
Active Comparator
Arm Description
At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally.
Intervention Type
Procedure
Intervention Name(s)
Transversalis Fascia Plane Block
Intervention Description
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Intervention Description
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally
Primary Outcome Measure Information:
Title
Postoperative quality of recovery
Description
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Time Frame
Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Title
Numeric Rating Scale
Description
A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Time Frame
Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Title
Adverse Reactions
Description
Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed
Time Frame
Postoperative 24th hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists physical status II-III
Cesarean section surgery under spinal anesthesia
Exclusion Criteria:
American Society of Anesthesiologists physical status IV
Emergency surgery
General anesthesia
Additional surgical intervention at the same session
Body mass index of more than 35 kg/m2
Allergy to any study drugs
Local infection at the injection site
History of drug abuse
Communication problem
Coagulopathy
Preeclampsia and eclampsia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melike Korkmaz Toker, Associate Professor
Phone
00905054747098
Email
meltoker@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melike Korkmaz Toker, Associate Professor
Organizational Affiliation
Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Training and Research Hospital
City
Mugla
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melike Korkmaz Toker, MD
Phone
00905054747098
Email
meltoker@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
via mail
Citations:
PubMed Identifier
29759061
Citation
Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.
Results Reference
background
PubMed Identifier
32412986
Citation
Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
Results Reference
background
Learn more about this trial
Comparison of the Quality of Recovery After Cesarean Section Surgery
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