Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773365
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-03-06
Brief Title:
PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Summary
Pain control after hip surgery is quite important for patients recovery Many regional techniques are available with the focus on motor sparing block to speed patient recovery
The investigators will compare pericapsular nerve group PENG block in addition to local skin infiltration to PENG block alone The study population will be included for patient traumatic hip surgery The study population will be divided into group First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block
Our primary outcome is to compare numeric rating scale NRS between studied groups and morphine requirements in the first 24 hours as a secondary outcome
Pain control after hip surgery is quite important for patients recovery Many regional techniques are available with the focus on motor sparing block to speed patient recovery
The investigators will compare pericapsular nerve group PENG block in addition to local skin infiltration to PENG block alone The study population will be included for patient traumatic hip surgery The study population will be divided into group First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block
Our primary outcome is to compare numeric rating scale NRS between studied groups and morphine requirements in the first 24 hours as a secondary outcome
Detailed Description:
Aim of the study
The aim of the study is to improve quality of patients post-operative recovery after hip surgery
Study objectives
To compare Patient numeric rating scale NRS scores after hip surgery for patients receiving PENG block and local skin infiltration
Study question
Will PENG block and local infiltration provide significant analgesia for hip surgery than PENG block alone
Null Hypothesis
Local infiltration addition to PENG block will not provide significant analgesia to PENG block alone
Alternative hypothesis
Local infiltration addition to PENG block will provide significant superior analgesia to PENG alone
Study Design
Single blinded randomized clinical trial Ethical approval will be obtained from Suez Canal University Patients enrolment will be obtained preoperatively Patients demographic data will be recorded age weight BMI and gender
An informed consent will be obtained during enrolment explaining the aim of the study and complication of the techniques Patient will have the right to withdraw from the study at any time
Patients will be randomly allocated to either of the studied group through the following method
Randomization of the patients meeting the inclusion criteria will be achieved by a computer-generated random sequence and this sequence will be concealed in sealed numbered envelopes labelled Group A study group carry the label Group B control group
Methods
Group A study group will receive both PENG block and local infiltration at the end of the surgery Group B control group will receive PENG block without local infiltration
Spinal anaesthesia will be administered to the patient using 10-125 mg heavy 05 bupivacaine at L3-L5 lumbar spine using 25 G spinal needle
If spinal anaesthesia is contraindicated or failed patients will have general anaesthetics
General anaesthesia will be induced with 1-2 mcgkg fentanyl propofol 1-2 mgkg and appropriate muscle relaxant
Block will be administered for trauma patients PENG block will be administered as following
A curvilinear US sound probe will be placed in a transverse plane over anterior superior iliac spine and rotated 45 degrees anticlockwise till identifying femoral vessels iliopubic eminence iliopsoas muscle tendon in the view A 100 mm echogenic needles SonoPlex STIM Germany will be advanced from lateral to medial and injecting 20 ml of 025 bupivacaine below the psoas tendon
A 20 ml of 025 bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery
Pain management
All patients will receive 1g of paracetamol 30 mg Ketorolac and 8 mg Dexamethasone after spinal anaesthesia
Postoperatively 1g of paracetamol four times a day ketorolac 30 mg twice a day for 48 hours Intravenous morphine 2 mg every 10 minutes will be given to the patient if NRS score 4 till pain is controlled as rescue analgesics
Morphine requirement will be assessed in recovery and then every 6 hours in the first 24 hours after surgery If the pain score 4 patient will get 2 mg IV morphine Pain will be reassessed after 10 minutes for further analgesia requirement
The aim of the study is to improve quality of patients post-operative recovery after hip surgery
Study objectives
To compare Patient numeric rating scale NRS scores after hip surgery for patients receiving PENG block and local skin infiltration
Study question
Will PENG block and local infiltration provide significant analgesia for hip surgery than PENG block alone
Null Hypothesis
Local infiltration addition to PENG block will not provide significant analgesia to PENG block alone
Alternative hypothesis
Local infiltration addition to PENG block will provide significant superior analgesia to PENG alone
Study Design
Single blinded randomized clinical trial Ethical approval will be obtained from Suez Canal University Patients enrolment will be obtained preoperatively Patients demographic data will be recorded age weight BMI and gender
An informed consent will be obtained during enrolment explaining the aim of the study and complication of the techniques Patient will have the right to withdraw from the study at any time
Patients will be randomly allocated to either of the studied group through the following method
Randomization of the patients meeting the inclusion criteria will be achieved by a computer-generated random sequence and this sequence will be concealed in sealed numbered envelopes labelled Group A study group carry the label Group B control group
Methods
Group A study group will receive both PENG block and local infiltration at the end of the surgery Group B control group will receive PENG block without local infiltration
Spinal anaesthesia will be administered to the patient using 10-125 mg heavy 05 bupivacaine at L3-L5 lumbar spine using 25 G spinal needle
If spinal anaesthesia is contraindicated or failed patients will have general anaesthetics
General anaesthesia will be induced with 1-2 mcgkg fentanyl propofol 1-2 mgkg and appropriate muscle relaxant
Block will be administered for trauma patients PENG block will be administered as following
A curvilinear US sound probe will be placed in a transverse plane over anterior superior iliac spine and rotated 45 degrees anticlockwise till identifying femoral vessels iliopubic eminence iliopsoas muscle tendon in the view A 100 mm echogenic needles SonoPlex STIM Germany will be advanced from lateral to medial and injecting 20 ml of 025 bupivacaine below the psoas tendon
A 20 ml of 025 bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery
Pain management
All patients will receive 1g of paracetamol 30 mg Ketorolac and 8 mg Dexamethasone after spinal anaesthesia
Postoperatively 1g of paracetamol four times a day ketorolac 30 mg twice a day for 48 hours Intravenous morphine 2 mg every 10 minutes will be given to the patient if NRS score 4 till pain is controlled as rescue analgesics
Morphine requirement will be assessed in recovery and then every 6 hours in the first 24 hours after surgery If the pain score 4 patient will get 2 mg IV morphine Pain will be reassessed after 10 minutes for further analgesia requirement
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