Inter-semispinal Plane Block and Cervical Spine Surgery (ISPB)

September 12, 2023 updated by: Yasser S Mostafa, MD

Inter-semispinal Plane (ISP) Block for Postoperative Analgesia Following Cervical Spine Surgery: A Prospective Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be performed in the in the Fayoum University hospital after the local Institutional Ethics Committee and local institutional review board approval. The study design will be double-blind randomized controlled study . A detailed informed consent will be signed by the eligible patients before recruitment and randomization.

Patients were randomly allocated into two groups using computer generated sequence and concealed in sealed opaque envelopes.

Control group (C): patients received general anesthesia only. Inter-semispinal plane (ISP) block group: patients received bilateral ultrasound guided ISP block at the level of C5.

All patients will be assessed Preoperative VAS score then premedicated orally with midazolam 0.5 mg/kg 30 min prior to surgery. All patients were monitored by 5 lead ECG, pulse oximetry, non-invasive blood pressure and capnography and an intravenous (IV) access will be established.

The technique of general anesthesia will be standardized for all patients. General anesthesia will be induced by intravenous (IV) 2 mg/kg propofol and 1 μg/kg fentanyl induction. After IV atracurium 0.5 mg/kg, orotracheal intubation was performed. Anesthesia will be maintained with isoflurane (1.2%-1.5%) in oxygen-air mixture (50%-50%). Muscle relaxation will be maintained during the procedure with atracurium in increments.

After induction of general anesthesia, ISP blocks will be performed in the allocated group with the patient in the prone position. In both groups, the treating anesthesiologist left the operating room while another anesthesiologist experienced in ultrasound guided nerve block techniques; with no subsequent role in the study; either performed the ISP blocks in the ISP group, or just prepared the skin and scanned the site of the block using the ultrasound probe in the control group. Fifteen minutes will be awaited in all patients before the surgical procedure was allowed to start.

fentanyl 0.5 μg/kg IV will be administered in case of inadequate analgesia as indicated by >20% increase in heart rate or mean arterial blood pressure. Total intraoperative fentanyl consumption will be recorded.

All anesthetics will be discontinued at the end of the surgical procedure. Extubation will be performed when spontaneous breathing was adequate and following prompt reversal using 0.05 mg/kg of neostigmine and 0.02 mg/kg of atropine. At the end of surgery, paracetamol 1 g will be administered IV to be repeated every 6 h postoperatively. Patients will be transferred to the PACU where HR, respiratory rate, SpO2 and systolic, diastolic and mean arterial blood pressure were monitored.

Sample size was calculated using G* Power 3.1.7.9 software program. Calculation of the sample size was based on the VAS value measured at different time points. Based on the results of a study by Mostafa et al, the authors calculated the sample size to be able to detect a difference in VAS score of 10 points with an effect size of 0.8. Using the previous data, at least 23 patients in each group were required to detect a significance difference in the postoperative pethidine consumption at α value of 0.05 and study power of 90%. The authors decided to recruit 25 patients in each group to compensate for any possible withdrawals. The sample size calculation was based on a 2-sample independent t-test (2-sided)

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Faiyum
      • Fayoum, Faiyum, Egypt, 63514
        • Fayoum University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
patients received general anesthesia only.
Experimental: ISP group
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
10 ml of 0.25% bupivacaine on each side of cervical region at C5
Other Names:
  • 0.25% bupivacaine HCL
Drug: Lidocaine Hydrochloride
10ml xylocaine on each side of cervical region at C5
Other Names:
  • Xylocaine
Device: Ultrasound
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.
Device: Needle
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative rescue pethidine consumption
Time Frame: 48 hours after operation
in milligram
48 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative visual analog pain score (VAS score)
Time Frame: 4 hours postoperatively
0 to 10 scale as 0: no pain and 10:worst degree of pain
4 hours postoperatively
Postoperative visual analog pain score (VAS score)
Time Frame: 8 hours postoperatively
0 to 10 scale as 0: no pain and 10:worst degree of pain
8 hours postoperatively
Postoperative visual analog pain score (VAS score)
Time Frame: 12 hours postoperatively
0 to 10 scale as 0: no pain and 10:worst degree of pain
12 hours postoperatively
Postoperative visual analog pain score (VAS score)
Time Frame: 24 hours postoperatively
0 to 10 scale as 0: no pain and 10:worst degree of pain
24 hours postoperatively
Postoperative visual analog pain score (VAS score)
Time Frame: 48 hours postoperatively
0 to 10 scale as 0: no pain and 10:worst degree of pain
48 hours postoperatively
time to first rescue analgesic request
Time Frame: 1 minute after requiring analgesics
in milligram
1 minute after requiring analgesics
Intraoperative fentanyl consumption
Time Frame: 1 minute after surgery.
in microgram
1 minute after surgery.
Occurrence of postoperative nausea
Time Frame: 2 hours after operation
yes or no
2 hours after operation
Occurrence of postoperative vomiting
Time Frame: 2 hours after operation
yes or no
2 hours after operation
Occurrence of postoperative pruritis
Time Frame: 2 hours after operation
yes or no
2 hours after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 1 hour preoperatively
in years
1 hour preoperatively
body mass index
Time Frame: 1 hour preoperatively
kg/m2
1 hour preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasser S Mostafa, MD

Investigators

  • Study Director: Mohamed A Shawky, MD, Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • m644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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