The comparison of analgesic and opioid- sparing effects of a preemptive single-shot epidural analgesia and unilateral single-injection Transversus Abdominis Plane block in patients undergoing renal sugeries
Eighty patients (20-60 y), candidate for renal surgeries under general anesthesia, are enrolled after taking written informed consent. They are randomized to receive Epidural analgesia or TAP block for post-op pain management. In group A, the lumbar epidural catheter is placed for patients in sitting position, before induction of anesthesia and a total volume of 15 cc (4 cc Bupivacaine 0.5% and 11 cc pure water) is injected. In group B, TAP block catheter is placed for patients under ultrasound guide in supine position after induction of anesthesia and before surgical incision and the same volume of LA is injected.
The same protocol of anesthesia with sodium thiopental and atracurium for induction and Propofol/Remifentanil infusion for maintenance are performed for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412063436N4
Registration date:2015-02-17, 1393/11/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-17, 1393/11/28
Registrant information
Name
Babak Gharaei
Name of organization / entity
Labbafijejad Hospital, Shahid Beheshti University of Medical Sciences
The comparison of analgesic and opioid- sparing effects of a preemptive single-shot epidural analgesia and unilateral single-injection Transversus Abdominis Plane block in patients undergoing renal sugeries
Public title
The comparison of analgesic effects of epidural and TAP block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria would be as follows:
1- ASA class I to II
2- Renal surgeries including open nephrectomy, radical nephrectomy, open surgery for renal or ureteral stones.
Exclusion criteria are as follows:
1- Long lasting surgery (more than three hours)
2- Chronic use of opioid
3- Complications such as severe hemorrhage
4- Intractable nausea and vomiting
5- Two episodes of intractable pain
6- More drug prescriptions other than protocol
7- Difficult airway
8- Drug allergy
9- Diabetes mellitus, Pregnancy, morbid obesity
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak,Tehran,Iran
City
Tehran
Postal code
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
308/14549
Health conditions studied
1
Description of health condition studied
Acute post-operative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
nephrectomy
ICD-10 code
Z90.5
ICD-10 code description
acquired absence of kidney
Primary outcomes
1
Description
post operative pain
Timepoint
24 hours after sugery
Method of measurement
VRS(Verbal Rating Scale)
2
Description
opioid use after surgery
Timepoint
24 hours after sugery
Method of measurement
mg
Secondary outcomes
1
Description
Bradypnea (RR <10)
Timepoint
after opioid use
Method of measurement
continuous observation
2
Description
itching
Timepoint
after opioid use
Method of measurement
observation
3
Description
vomiting
Timepoint
after opioid use
Method of measurement
observation
4
Description
hemorrhage during surgery
Timepoint
after intervention,during surgery
Method of measurement
observation (ml)
5
Description
hospital stay
Timepoint
after intervention
Method of measurement
patient file information
Intervention groups
1
Description
Lumbar epidural catheter placement and injection a total volume of15cc including 4cc bupivacaine 0.5% and 11cc pure water before induction of anesthesia
Category
Prevention
2
Description
perform unilateral TAP block at the site of surgery and injection a total volume of15cc including 4cc bupivacaine 0.5% and 11cc pure water after induction of anesthesia and 10 minutes before surgical incision