NCT07646184

Brief Summary

Spinal surgeries coincide with high level of pain due to extensive dissection and muscle retraction so inadequate pain control delays patient recovery, rehabilitation and also is an important source of patient dissatisfaction \[1\]. Non-steroidal anti-inflammatory drugs and opioids are used to control pain post spine surgeries. The side effects of opioids are nausea and vomiting (PONV), delirium, sedation, constipation, tolerance, respiratory depression, and high dependence \[2\]. Many efforts done by different studies to decrease the length of hospital stay and the dependence on opioids by using multimodal analgesic modalities including regional blocks by injection of local anesthesia before skin incision to block the pain pathway from the start. \[3\] The SPSM originates from C7-T2 (sometimes T3) spinous processes, progressing obliquely and inserting on the lateral of the second to fifth ribs' angle , The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) first described by Tulgar et al,\[4\] is a novel interfascial plane block that involves the injection of a local anesthetic between the Serratus posterior superior and intercostal muscles, dermatomal analysis of the patients showed sensory block reached the C3 dermatome in all patients in the cephalic direction. In the caudal direction, it was determined that sensory block reached at least the T7 dermatome in all patients. Erector spinae plane (ESP) block first described in 2016 by Forero et al. \[5\], it is a truncal block which inject (LA) between the thoracic transverse process and erector spinae muscle and spread to the thoracic paravertebral space thereby targeting the dorsal and ventral rami of spinal nerves \[6\]. Because they may provide an alternative to thoracic paravertebral blocks with fewer risks of pneumothorax, it is used to provide postoperative analgesia for thoracic and spine surgeries. And also used to manage chronic pain such as complex regional pain syndrome and failed back surgery syndrome \[2\]. Aim of the work: Compare the efficacy of serratus posterior superior intercostal plane block versus erector spinae plane block in thoracic spine surgeries at the level between T1 to T7 Primary outcome: NRS (Numerical rating scale) Secondary outcome: 1st dose of rescue analgesia, total doses of rescue analgesia, motor block, and 1st time of ambulation Patients and methods: This randomized double-blinded study will be carried out on 60 adult patients of both sexes undergoing elective thoracic spine surgeries in Tanta University Hospitals for a period of from April 2026 to December 2026. Informed written consent will be obtained from the parents. They will receive an explanation of the purpose of the study, and every patient will have a secret code number. All data of the patients will be confidential with secret codes and private files for each patient; all given data will be used for current medical research only. Any unexpected risks that appeared during the research will be cleared to the participants and ethical committee on time. Investigator who is blinded to group allocation provided postoperative care and assessments. Inclusion Criteria: adult patients of both sexes undergoing elective thoracic spine surgeries aged from 18 years to 60 years, ASA I or II, thoracic levels between T1 to T7 Exclusion Criteria: Parents refusal. Coagulopathy. Allergy to local anesthesia. Local infection at the site of injection. Pregnancy. Sever motor deficit (grade \< 2) and sever sensory deficit (grade \< 1). Randomization and blindness: Computer-generated randomization numbers will be used for random allocation and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into three groups in a parallel manner:

  • Group S (n=35): Serratus Posterior Superior Intercostal Plane Block will receive 30 ml of 0.25% bupivacaine on each side.
  • Group E (n=35): erector spinae block group will receive 20 ml of 0.25% bupivacaine on each side. Methods:
  • Preoperative:
  • Intraoperative:

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress12%
May 2026Dec 2026

Study Start

First participant enrolled

May 20, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 5, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • NRS (Numerical rating scale)

    2 months to 4 months

Secondary Outcomes (1)

  • 2ndry outecomes

    2 months for 4 months

Study Arms (2)

Group Serratus Posterior Superior Intercostal Plane Block

ACTIVE COMPARATOR

Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block

Procedure: Serratus Posterior Superior Intercostal Plane Block

Group erector spinae block

EXPERIMENTAL

Erector spinae block

Procedure: Erector spinae block

Interventions

Serratus Posterior Superior Intercostal Plane Block will receive 30 ml of 0.25% bupivacaine on each side.

Group Serratus Posterior Superior Intercostal Plane Block

Erector spinae block

Group erector spinae block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Parents refusal. Coagulopathy. Allergy to local anesthesia. Local infection at the site of injection. Pregnancy. Sever motor deficit (grade \< 2) and sever sensory deficit (grade \< 1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, State/Province:*, 0020, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted professor

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 12, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations