NCT05773365

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 18, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

March 6, 2023

Last Update Submit

December 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (1)

  • Morphine requirement

    24 hours

Study Arms (2)

Pericapsular Nerve Group Block plus local infiltration

EXPERIMENTAL

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.

Other: PENG block with or without local anaesthetic infiltration

Pericapsular Nerve Group Block

ACTIVE COMPARATOR

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

Other: PENG block with or without local anaesthetic infiltration

Interventions

As mentioned.

Pericapsular Nerve Group BlockPericapsular Nerve Group Block plus local infiltration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anaesthesiology (ASA) 1-3
  • Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw).

You may not qualify if:

  • Patient with cognitive impairment.
  • Patient weight \< 50 kg.
  • Allergy to medications used.
  • Chronic kidney disease. (serum creatinine \> 2.5 mg/dl).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University Hospital

Ismailia, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 24641893BACKGROUND
  • 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.

    PMID: 30635506BACKGROUND
  • 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.

    PMID: 30063657BACKGROUND
  • 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.

    PMID: 34196965BACKGROUND
  • 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.

    PMID: 35933328BACKGROUND

MeSH Terms

Conditions

PainHip FracturesPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPostoperative ComplicationsPathologic Processes

Study Officials

  • Eslam Albayadi

    Suez Canal University, Ring Road, Ismailia, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 17, 2023

Study Start

July 18, 2023

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations