Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144931
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-13
Brief Title:
Efficacy of Pericapsular Nerve Group PENG Block for Hip Surgeries
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
The Impact of Pericapsular Nerve Group Block on The Duration of Post-Operative Analgesia Following Hip Joint Surgeries
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the efficacy of the PENG block on the duration of postoperative analgesia There are two groups of patients who are undergoing hip joint surgeries one group Control Group will receive spinal anesthesia only while the other group PENG Group will receive PENG block before spinal anesthesia
Detailed Description:
Research Question
Is PENG block effective in prolonging the duration of postoperative analgesia when compared to patients undergoing spinal anesthesia only
Research Hypothesis
PENG block is effective in prolonging the duration of postoperative analgesia and reducing postoperative pain
Aim
To improve the outcome of hip joint surgeries by decreasing the postoperative pain and early mobilization by performing PENG block to patients undergoing hip joint surgeries
Method of randomization
This clinical trial will be randomized through computer software that generates random number table and patients will be allocated randomly to one of the two groups
Sample size
The sample size was determined by using the following equationCharan J et al 2013 N 2 δ2 Z_α Z_β2D2 δStandard deviation of the outcome 67 Pascarella et al 2021 Z_α The value for a type I error of 5 196 Z_βThe value for a type II error of 20 084 D2 The effect size 36 Pascarella et al 2021
By calculation
N 19 per group So the total sample size is 38
Procedures
After getting the informed consent from the patient the patient will be allocated into one of the study groups according to randomization
ASA standard monitors will be attached to the patient a wide pore cannula 18G will be inserted then a premedication with 50 -100 mcg of fentanyl and 1-2 mg midazolam intravenously will be given
PENG group PENG block will done under complete aseptic condition with 20 ml 025 bupivacaine diluted with normal saline Control group no block will be done Both groups will be anesthetized using spinal anesthesia with Bupivacaine
Study Variables
Independent variables age sex weight height body mass index BMI elective or emergency surgery duration of surgery American Society of Anesthesiologists physical status classification ASA score occupation fracture site type of trauma timing operating room entry- PENG block time- start of spinal anesthesia- start of surgery- end of surgery
Dependent variables Postoperative pain adverse events and postoperative motor assessment hemodynamics the first request of analgesia total analgesia required adverse events such as nausea vomiting sedation pain scores at preparation room after PENG block during sitting for spinal anesthesia at end of the surgery postoperative intervalsrest movement
Is PENG block effective in prolonging the duration of postoperative analgesia when compared to patients undergoing spinal anesthesia only
Research Hypothesis
PENG block is effective in prolonging the duration of postoperative analgesia and reducing postoperative pain
Aim
To improve the outcome of hip joint surgeries by decreasing the postoperative pain and early mobilization by performing PENG block to patients undergoing hip joint surgeries
Method of randomization
This clinical trial will be randomized through computer software that generates random number table and patients will be allocated randomly to one of the two groups
Sample size
The sample size was determined by using the following equationCharan J et al 2013 N 2 δ2 Z_α Z_β2D2 δStandard deviation of the outcome 67 Pascarella et al 2021 Z_α The value for a type I error of 5 196 Z_βThe value for a type II error of 20 084 D2 The effect size 36 Pascarella et al 2021
By calculation
N 19 per group So the total sample size is 38
Procedures
After getting the informed consent from the patient the patient will be allocated into one of the study groups according to randomization
ASA standard monitors will be attached to the patient a wide pore cannula 18G will be inserted then a premedication with 50 -100 mcg of fentanyl and 1-2 mg midazolam intravenously will be given
PENG group PENG block will done under complete aseptic condition with 20 ml 025 bupivacaine diluted with normal saline Control group no block will be done Both groups will be anesthetized using spinal anesthesia with Bupivacaine
Study Variables
Independent variables age sex weight height body mass index BMI elective or emergency surgery duration of surgery American Society of Anesthesiologists physical status classification ASA score occupation fracture site type of trauma timing operating room entry- PENG block time- start of spinal anesthesia- start of surgery- end of surgery
Dependent variables Postoperative pain adverse events and postoperative motor assessment hemodynamics the first request of analgesia total analgesia required adverse events such as nausea vomiting sedation pain scores at preparation room after PENG block during sitting for spinal anesthesia at end of the surgery postoperative intervalsrest movement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None