Protocol summary

Study aim
Determination of the effect of transversus abdominis plane block with Ropivacaine 0.5% in relieving postoperative pain after laparoscopic gynecologic surgery
Design
This study is a clinical trial with a control group, parallel-group design, double-blinded and randomized.
Settings and conduct
The population of the study included 200 women candidates for elective laparoscopic gynecologic surgery who referred to Alzahra hospital in Isfahan during 2016-2017. The intervention is done at the operating room. Severity of pain and nausea and vomiting is recorded at the time of recovery, at 30 minutes, 2, 4, 6, 12, and 48 hours after surgery. For evaluating the severity of pain, visual analogue scale (VAS), based on a score of 0 (painless) to 10 (most pain) was used. Peptidine and diclofenac suppository were used if necessary at the time of no pain reduction (pain more than 3). Nausea and vomiting were also determined based on a score of 0 to 3 (0 means non-existence, 1 means mild, 2 means moderate and 3 means severe).
Participants/Inclusion and exclusion criteria
Inclusion criteria : Candidate for laparoscopic gynecologic surgeries (such as ovarian cystectomy and hysterectomy); willingness to participate in the study. Exclusion criteria: Having a history of allergy to the agents used in the study; suffering from acute and/or chronic preoperative pains.
Intervention groups
Intervention group: In this group, in addition to standard spinal anesthesia, an anesthetic drug Ropivacaine (Naropin,0.5%) was injected at a dose of 0.5 mg / kg between transverse abdominal muscle and internal oblique muscle facia. Control group: Patients in this group just received standard spinal anesthesia.
Main outcome variables
severity of pain; severity of nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042618N3
Registration date: 2019-03-31, 1398/01/11
Registration timing: retrospective

Last update: 2019-03-31, 1398/01/11
Update count: 0
Registration date
2019-03-31, 1398/01/11
Registrant information
Name
najme bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 8235
Email address
st_bagherin@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-19, 1395/02/30
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2016-05-19, 1395/02/30
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2018-05-02, 1397/02/12
Scientific title
Comparing the efficacy of standard spinal anesthesia and transversus abdominis plane block with Ropivacaine 0.5% on relieving the postoperative pain after laparoscopic gynecologic surgery
Public title
The effect of transversus abdominis plane block with Ropivacaine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for laparoscopic gynecologic surgery (such as ovarian cystectomy and hysterectomy) Willingness to participate in the study
Exclusion criteria:
Having a history of allergy to the agents used in the study suffering from acute and/or chronic preoperative pains
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 200
Actual sample size reached: 200
Randomization (investigator's opinion)
Randomized
Randomization description
200 eligible patients were recruited to the study through easy non-randomization method. Then we randomly assigned patients to a treatment or control groups through simple randomization method using random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were randomly assigned to one of the two groups before surgery. Then their group was recorded by the ward secretary and the list was given to the anesthetist. The patients were kept unaware from the groups they were allocated. Then the patients in the intervention group underwent transversus abdominis plane block by an anesthetist. After the surgery, a student who was unaware of the allocation, completed the post-operative pain and other symptoms cheklists and delivered to the secretary.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Esfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib street
City
Esfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.MUI.REC.1396.913

Health conditions studied

1

Description of health condition studied
Pain after laparoscopic gynecologic surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of pain
Timepoint
At the time of recovery, 30 minutes, 2, 4, 6, 12, and 48 hours after surgery
Method of measurement
VAS (Visual analogue scale)

2

Description
Severity of nausea and vomiting
Timepoint
At the time of recovery, 30 minutes, 2, 4, 6, 12, and 48 hours after surgery
Method of measurement
Based on questionnaire and its scoring (0 = no nausea and vomiting, 1 = mild, 2 = moderate and 3 = severe)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, in addition to standard spinal anesthesia, an anesthetic drug Ropivacaine (Naropin,0.5%) was injected at a dose of 0.5 mg / kg between transverse abdominal muscle and internal oblique muscle facia.
Category
Prevention

2

Description
Control group: Patients in this group just received standard spinal anesthesia.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Ata Allah Ghahiri
Street address
Alzahra Hospital, Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1668 5555
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciiences, Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Atoullah Ghahiri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetric and gynecology department, Alzahra Hospital, Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1668 5555
Email
ghahiri@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ata Allah Ghahiri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetric and gynecology department, Alzahra Hospital, Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1668 5555
Email
ghahiri@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ata Allah Ghahiri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Obstetric and gynecology department, Alzahra Hospital, Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1668 5555
Email
ghahiri@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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