NCT06144931

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 13, 2023

Last Update Submit

November 17, 2023

Conditions

Keywords

PENGHip Joint Surgeriespostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • The time of first request of analgesia in both groups

    The time of first request of analgesia in both groups in minutes

    24 hours postoperative

Secondary Outcomes (4)

  • Evaluate the morphine consumption over the first 24 hours.

    24 hours postoperative

  • Evaluate the regaining of motor function of quadriceps muscle in both groups

    24 hours postoperative

  • The incidence of occurrence of side effects related to the technique and medications in both groups

    24 hours postoperative

  • difference in Visual Analogue Score (VAS) pain score in the first 24 hours postoperative between the two groups

    first 24 hours postoperative

Study Arms (2)

Control Group

NO INTERVENTION

Patients in this group will be operated under spinal anesthesia

PENG Group

ACTIVE COMPARATOR

Patients in this group will undergo PENG block guided by ultrasound then spinal anesthesia will performed

Procedure: PENG Block

Interventions

PENG BlockPROCEDURE

With the patient in the supine position, the ultrasound probe is placed on a transverse plane over the anterior superior iliac spine (ASIS). Once the ASIS is identified, the transducer is aligned with the pubic ramus and rotated at approximately 45 degrees, parallel to the inguinal crease. The transducer then slides medially along this axis until the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), and the psoas tendon is clearly identified, serving as anatomic landmarks. Sliding the probe distally or gently tilting the caudal will expose the head of the femur. Returning to the initial starting position, a standard 22 gauge spinal needle is inserted in-plane, from lateral to medial, in the plane between the psoas tendon and the pubic ramus. 20 ml 0.25% bupivacaine diluted with preservative free normal saline then deposited in this plane, lifting the psoas tendon. Care should be taken to avoid puncturing the psoas tendon.

PENG Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hip fracture who will be subjected to surgical treatment
  • ASA physical status 1, 2

You may not qualify if:

  • Patients with chronic pain before surgery (taking opioids).
  • Patients with multiple trauma
  • Patients who could not assess pain reliably (dementia).
  • Substance abuse and prolonged intake of sedative drugs.
  • Morbid obese patients (BMI\>35).
  • Patients who have open wounds or infection at the site of the block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and Intensive Care

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 22, 2023

Study Start

June 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations