Inter-semispinal Plane Block and Cervical Spine Surgery

NCT06003933 | Completed

• 1 other identifier: m644
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves local anesthetic injection into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles with subsequent block of the dorsal rami of the cervical spinal nerves and hence can get adequate postoperative analgesia. The authors hypothesized that ISP block can reduce the postoperative analgesic consumption in patients undergoing posterior cervical spine surgeries. The aim of this study is to evaluate the analgesic efficacy of ISP block in patients undergoing posterior cervical spine surgery.

Conditions

Post Operative Pain; Cervical Spine Instability

Keywords

inter-semispinal plane block; Cervical spine surgery; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• postoperative rescue pethidine consumption

  in milligram

  48 hours after operation

Secondary Outcomes (10)

• Postoperative visual analog pain score (VAS score)

  4 hours postoperatively

• Postoperative visual analog pain score (VAS score)

  8 hours postoperatively

• Postoperative visual analog pain score (VAS score)

  12 hours postoperatively

• Postoperative visual analog pain score (VAS score)

  24 hours postoperatively

• Postoperative visual analog pain score (VAS score)

  48 hours postoperatively

Other Outcomes (2)

• Age

  1 hour preoperatively

• body mass index

  1 hour preoperatively

Study Arms (2)

Control group

NO INTERVENTION

patients received general anesthesia only.

ISP group

EXPERIMENTAL

patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity

Drug: Bupivacaine Hydrochloride; Drug: Lidocaine Hydrochloride; Device: Ultrasound; Device: Needle

Interventions

Bupivacaine Hydrochloride DRUG

10 ml of 0.25% bupivacaine on each side of cervical region at C5

Also known as: 0.25% bupivacaine HCL

ISP group

Lidocaine Hydrochloride DRUG

10ml xylocaine on each side of cervical region at C5

Also known as: Xylocaine

ISP group

Ultrasound DEVICE

The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block.The five-layered posterior cervical muscles were identified at the level of C5 with a 6-15-MHz linear probe oriented in the transverse plane (SonoSite Edge, Bothell, Washington). The fifth cervical spine was counted from the C7 spinous process with the probe sliding cranially.

ISP group

Needle DEVICE

the needle (22- G, 50-mm block needle (Visioplex, Vygon) was introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of bupivacaine 0.25% was injected5.

ISP group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II undergoing elective posterior cervical spine surgery

You may not qualify if:

• Patient refusal
• Patients with any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality)
• Known allergy to local anesthetics
• Previous cervical disc surgery or fixation
• Mental disorders
• Drug or alcohol abuse.

Sponsors & Collaborators

• Yasser S Mostafa, MD: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

• Kurd MF, Kreitz T, Schroeder G, Vaccaro AR. The Role of Multimodal Analgesia in Spine Surgery. J Am Acad Orthop Surg. 2017 Apr;25(4):260-268. doi: 10.5435/JAAOS-D-16-00049.

  PMID: 28291143 BACKGROUND

• Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.

  PMID: 30853517 BACKGROUND

• Lumawig JM, Yamazaki A, Watanabe K. Dose-dependent inhibition of diclofenac sodium on posterior lumbar interbody fusion rates. Spine J. 2009 May;9(5):343-9. doi: 10.1016/j.spinee.2008.06.455. Epub 2008 Sep 14.

  PMID: 18790686 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Lidocaine; Ultrasonography; Needles

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Equipment and Supplies

Study Officials

• Mohamed A Shawky, MD

  Fayoum University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia

Model Details: Patients were randomly allocated into either of the two groups using computer generated sequence and concealed in sealed opaque envelopes.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: March 3, 2023
• Primary Completion: August 15, 2023
• Study Completion: September 10, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)