Protocol summary

Summary
(1)General objective: Comparing the duration of analgesia after posterior and lateral transverse abdominal blocks under ultrasound guidance after cesarean section. (2)Design: No placebo-controlled, one center, randomized, double blind late stage clinical trial (a) all women 18 to 50 years who were referred for elective or emergency cesarean section to general operating room of Rasoul Akram Hospital, Sample size: 76, intervension period:2015-2016. (3)Setting, conduct and Intervention: For all patients undergoing elective cesarean section after spinal anesthesia and analgesia, Monitoring (pulse oximetry, non-invasive measurement of blood pressure and electrocardiogram), and IV line and 500 ml ringer therapy were performed. Spinal anesthesia was done in the sitting position and in sterile conditions with a needle (25 dr japan) and 10 mg of bupivacaine (maylan made in france) for all patients in the operating room. After reaching the T4 level of anesthesia, cesarean section was begun. When systolic blood pressure decreased to less than 80 mm Hg or the drop was more than 30%, 10 mg of ephedrine was injected and in the case of heart rate drop to less than 50 beats per minute, atropine 0.5 mg was injected. After the cesarean and in the recovery room, patients randomly divided into two groups and all patients were monitored (pulse oximetry, non-invasive measurement of blood pressure and electrocardiogram). When the level of spinal anesthesia decreased 2 to 3 levels compared to T4 (The assessment by pin prink and cotton alcohol on the anterior abdomen), 15 cc of bupivacaine 0.25% (Bupivacaine maylan made in france) using a 23 gauge spinal needle (dr japan) was injected in the SUPINE position under the guidance of linear ultrasound probe (Mark SonoSite made in USA) In sterile conditions. In one group lateral TAP block has been done on the midaxillary line in the border of coastal margine and iliac crest between internal oblique and transverse abdominis the local anaesthetic bilaterally. The other group went under the posterior Tap block (quaderotus lombrum) in the triangular space of petit (the inferior margin of iliac crest and the posterior border of the latissimus dorsi muscle and anterior border external oblique muscle). (4)Participants including major eligibility criteria: Patients were divided to two groups. each group were consist of 38 patients. Inclusion criteria: patients 18 to 50 years old undergoing spinal anesthesia for cesarean section. Exclusion criteria: Patients in the ASA class 3 and more; patients that spinal anesthesia was not successful in them; patients with underlying organic diseases; being allergic to bupivacaine. (5)Main outcome measures: Pain intensity at rest, Pain intensity in coughing situation, opioid need

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016120431225N1
Registration date: 2017-03-12, 1395/12/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Maryam Ghaderi Ashtiani
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2675 4974
Email address
m.ghaderi.ashtiani@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2015-12-21, 1394/09/30
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the duration of analgesia following two method of posterior and lateral transverse abdominal blocks under ultrasound guidance after cesarean section
Public title
Transverse muscle block effect in analgesia after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-50 year old females who are candidate for spinal anesthesia for elective and emergency cesarean section due to fetal distress; patients with ASA 1 & 2. Exclusion criteria: patients with ASA>3 & 4; contraindication for the use of spinal anesthesia; Emergent conditions due to organic problems such as eclampsia, preeclampsia, placenta previa and ...; history of allergy to bupivacaine; receiving an analgesic; BMI> 40; pre-pregnancy weight less than 50 kg; patients with an underlying disease or history of renal or liver disease or coagulopathy; prediction of spinal anesthesia unsuccessfulness (including inadequate anesthetic level); patients who have received sedation drugs fentanyl 100 macrograms and midazolam 2 miligrams during the procedure.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To create analgesia in the lower abdomen after surgery, there are two main ways that we decided to compare the efficacy of both.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University Of Medical Sciences, Next to Milad tower, Hemmat highway
City
Tehran
Postal code
1449614535
Approval date
2015-12-20, 1394/09/29
Ethics committee reference number
IR.IUMS.REC.1394.9211174015

Health conditions studied

1

Description of health condition studied
acute pain after cesarean section
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Satisfaction of Analgesia
Timepoint
Immediately after the caesarean section and at 2, 4, 6, 12, 24 and 36 hours after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Time of first opioid analgesic injection
Timepoint
The first time analgeic request by the patient
Method of measurement
Questionnaire

2

Description
Pain relief score at rest
Timepoint
2, 4, 6, 12, 24, 36 hours after intervention
Method of measurement
Pain Score Questionnaire (zero to ten)

3

Description
Patient satisfaction score
Timepoint
36 hours after intervention
Method of measurement
Questionnaire

4

Description
Nausea and vomiting complaint
Timepoint
2, 4, 6, 12, 24, 36 hours after intervention
Method of measurement
Questionnaire

5

Description
amount of opioid consumption (mg)
Timepoint
36 hours after intervention
Method of measurement
Questionnaire

6

Description
Pain relief score when coughing
Timepoint
2, 4, 6, 12, 24, 36 hours after intervention
Method of measurement
Pain Score Questionnaire (zero to ten)

Intervention groups

1

Description
Intervention group 1: Posterior TAP block (quaderotus lumbrum) in the triangular space of petit (iliac crest and the inferior margin of the posterior border of the latissimus dorsi muscle and anterior of external oblique muscle). When the probe was in posterior axillary position (the exact location of the posterior block quaderotus Lombrum), sono anatomy at the first stage showed transverse abdominis and then internal and external oblique that were doing aponeurosis. Needle(number 23 dr japan) was inserted at the junction of abdominal and quaderotus lombrum muscles and 15 cc bupivacaine 0.25%(maylan made in france) was injected bilaterally. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels.
Category
Rehabilitation

2

Description
Intervention group 2: lateral tap block was performed through the local injection of 15 cc anesthetic bupivacaine 0.25% using 23 gauge spinal needle (dr japan) at the junction of midaxillary line and transverse umblical line (between Coastal margin and iliac crest) between internal oblique and transverse abdominis muscles. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Anesthesiology and Pain, Rasoul Akram Hospital
Full name of responsible person
Maryam Ghaderi Ashtiani (MD), Senior Resident Of Anesthesiology
Street address
Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Maryam Ghaderi Ashtiani (MD)
Street address
Iran University Of Medical Sciences, Next to Milad tower, Hemmat boulevard
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Poupak Rahimzadeh(MD)
Position
Anesthesiologist/Pain Fellowship, Department of Anesthesiology and Pain
Other areas of specialty/work
Street address
Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street
City
Tehran
Postal code
1445613131
Phone
+98 21665173419
Fax
+98 21665173419
Email
Poupak_rah@hotmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasool Akram Hospital
Full name of responsible person
Poupak Rahimzade(MD)
Position
Anesthesiologist/Pain Fellowship, Department of Anesthesiology and Pain
Other areas of specialty/work
Street address
Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street
City
Tehran
Postal code
1445613131
Phone
+98 21665173419
Fax
+98 21665173419
Email
Poupak_rah@hotmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Rasool Akram Hospital
Full name of responsible person
Poupak Rahimzade (MD)
Position
Anesthesiologist/Pain Fellowship, Department of Anesthesiology and Pain
Other areas of specialty/work
Street address
Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street
City
Tehran
Postal code
1445613131
Phone
+98 21665173419
Fax
+98 21665173419
Email
Poupak_rah@hotmail.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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