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PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery

Primary Purpose

Pain, Hip Fractures, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PENG block with or without local anaesthetic infiltration
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anaesthesiology (ASA) 1-3 Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw). Exclusion Criteria: Patient with cognitive impairment. Patient weight < 50 kg. Allergy to medications used. Chronic kidney disease. (serum creatinine > 2.5 mg/dl).

Sites / Locations

  • Suez Canal University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pericapsular Nerve Group Block plus local infiltration

Pericapsular Nerve Group Block

Arm Description

Group A (study group) will receive both PENG block and local infiltration at the end of the surgery. Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% 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 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required. PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon. A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.

In Group B, only PENG block will be administered in this arm

Outcomes

Primary Outcome Measures

Pain scores
The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.

Secondary Outcome Measures

Morphine requirement
Postoperative morphine requirement

Full Information

First Posted
March 6, 2023
Last Updated
August 19, 2023
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05773365
Brief Title
PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery
Official Title
Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Aim of the study: The aim of the study is to improve quality of patient's 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 10-12.5 mg heavy 0.5% 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 mcg/kg fentanyl, propofol 1-2 mg/kg, 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 0.25% bupivacaine below the psoas tendon. A 20 ml of 0.25% 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hip Fractures, Postoperative Pain, Postoperative Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular Nerve Group Block plus local infiltration
Arm Type
Experimental
Arm Description
Group A (study group) will receive both PENG block and local infiltration at the end of the surgery. Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% 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 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required. PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon. A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.
Arm Title
Pericapsular Nerve Group Block
Arm Type
Active Comparator
Arm Description
In Group B, only PENG block will be administered in this arm
Intervention Type
Other
Intervention Name(s)
PENG block with or without local anaesthetic infiltration
Intervention Description
As mentioned.
Primary Outcome Measure Information:
Title
Pain scores
Description
The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Morphine requirement
Description
Postoperative morphine requirement
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anaesthesiology (ASA) 1-3 Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw). Exclusion Criteria: Patient with cognitive impairment. Patient weight < 50 kg. Allergy to medications used. Chronic kidney disease. (serum creatinine > 2.5 mg/dl).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eslam G Albayadi, MD
Phone
+201223666764
Email
islam.gamal@med.suez.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman Soliman, MD
Phone
+201001104478
Email
abdul_rahman_ahmed@med.suez.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eslam Albayadi
Organizational Affiliation
Suez Canal University, Ring Road, Ismailia, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suez Canal University Hospital
City
Ismailia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eslam Albayadi
Phone
+201223666764

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24641893
Citation
Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):13-21. doi: 10.3113/jsoa.2014.0013.
Results Reference
background
PubMed Identifier
30635506
Citation
Tran DQ, Salinas FV, Benzon HT, Neal JM. Lower extremity regional anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-000019. doi: 10.1136/rapm-2018-000019. Online ahead of print.
Results Reference
background
PubMed Identifier
30063657
Citation
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
Results Reference
background
PubMed Identifier
34196965
Citation
Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
Results Reference
background
PubMed Identifier
35933328
Citation
Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
Results Reference
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PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery

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