Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369948
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-31
Brief Title:
Quality Of Recovery After Pericapsular Nerve Group PENG Block For Hip Hemiarthroplasty Under Spinal Anesthesia
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Quality Of Recovery After Pericapsular Nerve Group PENG Block For Hip Hemiarthroplasty Under Spinal Anesthesia A Prospective Double-Blinded Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery There is a wide range of regional anesthetic techniques The most common in this anatomical region and those with the greatest published research are fascia iliac block lumbar plexus block and femoral nerve block Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks Novel techniques including local infiltration analgesia and quadratus lumborum block have been reported
While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful they come with a risk of undesired lower limb muscle weakness On the other hand the fascia iliac block does not always offer sufficient pain relief following hip surgery The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation
This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block PENG which blocks these nerves to target the hips anterior capsule The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block PENG for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty
While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful they come with a risk of undesired lower limb muscle weakness On the other hand the fascia iliac block does not always offer sufficient pain relief following hip surgery The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation
This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block PENG which blocks these nerves to target the hips anterior capsule The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block PENG for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty
Detailed Description:
This study will be performed in the Fayoumi University Hospital after approval by the local Institutional Ethics Committee and local institutional review board The study design will be a double-blinded randomized controlled study trial The researcher will inform the participants about the objectives of the study the examination and the investigation that will be done Also the confidentiality of their information and their right not to participate in the study Written informed consent will be obtained from all patients included in the study
The study will include 60 patients who will undergo elective hip hemiarthroplasty Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block
Pericapsular Nerve Group PENG Block P group includes 30 patients who will receive a PENG block
Control group C group includes 30 patients who will not receive a PENG block A full medical history will be taken from the included patients including demographic data age body mass index weight gender general medical history Diabetes Hypertension medication use anesthesia and previous surgeries The patients fasting durations will be 8 hours for solids and 2 hours for clear liquids All patients will be assessed Preoperative for VAS score All patients were monitored by 5 lead ECG pulse oximetry non-invasive blood pressure and an intravenous access will be established
The technique of spinal anesthesia will be standardized for all patients an attending anesthesiologist will use a 25-gauge Quincke spinal needle Spinocan B Braun Melsungen AG Germany to induce spinal anesthesia in the L34 or L45 vertebral interspace Throughout the course of the trial the attending anesthesiologist will chose the dosages of 05 hyperbaric bupivacaine 10 to 15 mg and fentanyl 15 mcg aiming for a sensory block at the T4 level The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds Three minutes following the spinal injection the sensory block was evaluated with a cold and pinprick test The patient will be placed in a supine position neutral-head resting posture in the operating area as standard monitors that mentioned before
Data will be gathered coded to make data manipulation easier double-entered into Microsoft Access and will be analyzed using SPSS software version 22 running on Windows 7 SPSS Inc Chicago IL USA Simple descriptive analysis will use percentages and numbers for qualitative data arithmetic means for measuring central tendency and standard deviations for quantifying dispersion for parametric quantitative data
- For quantitative data Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data
For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups
Sensitivity and specificity test for testing a new test with ROC curve Receiver Operating Characteristic
The P-value 005 will be considered statistically significant
The study will include 60 patients who will undergo elective hip hemiarthroplasty Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block
Pericapsular Nerve Group PENG Block P group includes 30 patients who will receive a PENG block
Control group C group includes 30 patients who will not receive a PENG block A full medical history will be taken from the included patients including demographic data age body mass index weight gender general medical history Diabetes Hypertension medication use anesthesia and previous surgeries The patients fasting durations will be 8 hours for solids and 2 hours for clear liquids All patients will be assessed Preoperative for VAS score All patients were monitored by 5 lead ECG pulse oximetry non-invasive blood pressure and an intravenous access will be established
The technique of spinal anesthesia will be standardized for all patients an attending anesthesiologist will use a 25-gauge Quincke spinal needle Spinocan B Braun Melsungen AG Germany to induce spinal anesthesia in the L34 or L45 vertebral interspace Throughout the course of the trial the attending anesthesiologist will chose the dosages of 05 hyperbaric bupivacaine 10 to 15 mg and fentanyl 15 mcg aiming for a sensory block at the T4 level The patient will be placed in the sitting or left lateral position while the spinal injection is given over a period of 15 to 30 seconds Three minutes following the spinal injection the sensory block was evaluated with a cold and pinprick test The patient will be placed in a supine position neutral-head resting posture in the operating area as standard monitors that mentioned before
Data will be gathered coded to make data manipulation easier double-entered into Microsoft Access and will be analyzed using SPSS software version 22 running on Windows 7 SPSS Inc Chicago IL USA Simple descriptive analysis will use percentages and numbers for qualitative data arithmetic means for measuring central tendency and standard deviations for quantifying dispersion for parametric quantitative data
- For quantitative data Independent samples t-test will be used to compare quantitative measures between two independent groups Paired t-test will be used to compare two dependent quantitative data
For qualitative data The Chi-square test will be used to compare two of more than two qualitative groups
Sensitivity and specificity test for testing a new test with ROC curve Receiver Operating Characteristic
The P-value 005 will be considered statistically significant
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