NCT07340801

Brief Summary

Recent advances in regional anesthesia techniques have aimed to provide more targeted and effective pain relief. Among these, the erector spinae plane (ESPB) block, the multifidus cervicis plane (MCP) block, and the paraspinal interfascial plane block (PIP) is rapidly expanding in cervical spine surgery. Of these, the inter-semispinal fascial plane block (ISPB) has gained popularity as an analgesic technique for posterior cervical spine surgery also, (ESPB) have been tried successfully for posterior cervical spine surgery in few recent trials. But to our knowledge, no study compared the efficacy of both blocks. So, the current study aimed to compare the analgesic efficacy of inter-semispinal fascial plane block versus erector spinae plane block in patients undergoing elective posterior cervical spine surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Analgesia

Keywords

the inter-semispinal fascial plane block (ISPB)the erector spinae plane (ESPB) blockPosterior cervical surgeries

Outcome Measures

Primary Outcomes (1)

  • The total perioperative opioid consumption

    the total perioperative opioid consumption through two co-primary outcomes, i.e. total amount of fentanyl administered intraoperatively and total fentanyl consumption during the first 24 hours postoperatively.

    during the first 24 hours postoperatively

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

an ultrasound-guided bilateral inter-semispinal fascial plane block (ISPB) will be performed and injection of 15 mL Bupivacaine 0.25% on each side

Drug: Bupivacaine

Group (B)

ACTIVE COMPARATOR

an ultrasound-guided bilateral erector spinae plane block (ESPB) will be performed and injection of 15 mL Bupivacaine 0.25% on each side

Drug: Bupivacaine

Interventions

BupivacaineDRUG

injection of 15 mL Bupivacaine 0.25% on each side

Group (A)Group (B)

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older.
  • Patients Scheduled for Elective Posterior Cervical Spine Surgery.
  • American Society of Anesthesiologists (ASA) physical status I-III.

You may not qualify if:

  • Patients with traumatic or emergency surgeries.
  • Renal or hepatic impairment
  • Allergy to drug used.
  • Re-do surgery.
  • Coagulopathy.
  • Neuromuscular disease.
  • Preoperative poor left ventricular function (EF \< 35%).
  • Systemic infections or infections at site of injection.
  • Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
  • Narcotic dependency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63511, Egypt

Location

Related Publications (2)

  • Mahmoud AM, Alsaied MA, Ragab SG, Abdelfattah YA, Farghaly OS, Shawky MA. Inter-Semispinalis Plane Block Versus General Anesthesia for Postoperative Analgesia in Posterior Cervical Spine Surgery: A Randomized Controlled Trial. Anesth Pain Med. 2024 Feb 16;14(1):e143369. doi: 10.5812/aapm-143369. eCollection 2024 Feb.

    PMID: 38725919BACKGROUND

  • Abdelhaleem NF, Youssef EM, Hegab AS. Analgesic efficacy of inter-semispinal fascial plane block in Patients undergoing Cervical Spine Surgery through Posterior Approach: a randomized controlled trial. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101213. doi: 10.1016/j.accpm.2023.101213. Epub 2023 Mar 7.

    PMID: 36894055BACKGROUND

MeSH Terms

Conditions

AgnosiaBites and Stings

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mahdy Abdelhady, MD

    Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Anesthesiology

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

November 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)