NCT06818396

Brief Summary

It is already known that fascia iliaca compartment block and intrathecal nalbuphine are very effective ways in postoperative pain control in patients having hip surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2025

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
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

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

February 5, 2025

Last Update Submit

November 15, 2025

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia (minutes).

    Time to first rescue analgesia (minutes).

    in the first 24 hours after surgery

Study Arms (3)

US-guided fascia iliaca compartment block (FICB) and spinal anesthesia

ACTIVE COMPARATOR
Other: US-guided fascia iliaca compartment block (FICB) and spinal anesthesia

Intrathecal nalbuphine and spinal anesthesia

ACTIVE COMPARATOR
Drug: Intrathecal nalbuphine and spinal anesthesia

Spinal anesthesia

OTHER
Other: Spinal anesthesia

Interventions

US-guided fascia iliaca compartment block (FICB) and spinal anesthesiaOTHER

US-guided fascia iliaca compartment block (FICB) and spinal anesthesia

US-guided fascia iliaca compartment block (FICB) and spinal anesthesia
Intrathecal nalbuphine and spinal anesthesiaDRUG

intrathecal nalbuphine and spinal anesthesia

Intrathecal nalbuphine and spinal anesthesia
Spinal anesthesiaOTHER

Spinal anesthesia

Spinal anesthesia

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) score (ASA I- ASA II).
  • Age ≥ 21years.
  • Body mass index \< 35 kg/m2

You may not qualify if:

  • Patient's refusal.
  • Known coagulopathy.
  • Known peripheral neuropathy or neurological deficits.
  • Known allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care,Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

February 18, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

EG(1)