search
Back to results

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

Primary Purpose

Post Operative Pain, Cervical Spine Instability

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Lidocaine Hydrochloride
Ultrasound
Needle
Sponsored by
Yasser S Mostafa, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring inter-semispinal plane block, Cervical spine surgery, Postoperative analgesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fayoum University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

ISP group

Arm Description

patients received general anesthesia only.

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

Outcomes

Primary Outcome Measures

postoperative rescue pethidine consumption
in milligram

Secondary Outcome Measures

Postoperative visual analog pain score (VAS score)
0 to 10 scale as 0: no pain and 10:worst degree of pain
Postoperative visual analog pain score (VAS score)
0 to 10 scale as 0: no pain and 10:worst degree of pain
Postoperative visual analog pain score (VAS score)
0 to 10 scale as 0: no pain and 10:worst degree of pain
Postoperative visual analog pain score (VAS score)
0 to 10 scale as 0: no pain and 10:worst degree of pain
Postoperative visual analog pain score (VAS score)
0 to 10 scale as 0: no pain and 10:worst degree of pain
time to first rescue analgesic request
in milligram
Intraoperative fentanyl consumption
in microgram
Occurrence of postoperative nausea
yes or no
Occurrence of postoperative vomiting
yes or no
Occurrence of postoperative pruritis
yes or no

Full Information

First Posted
August 15, 2023
Last Updated
September 12, 2023
Sponsor
Yasser S Mostafa, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT06003933
Brief Title
Inter-semispinal Plane Block and Cervical Spine Surgery
Acronym
ISPB
Official Title
Inter-semispinal Plane (ISP) Block for Postoperative Analgesia Following Cervical Spine Surgery: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
September 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasser S Mostafa, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Cervical Spine Instability
Keywords
inter-semispinal plane block, Cervical spine surgery, Postoperative analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly allocated into either of the two groups using computer generated sequence and concealed in sealed opaque envelopes.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients received general anesthesia only.
Arm Title
ISP group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
0.25% bupivacaine HCL
Intervention Description
10 ml of 0.25% bupivacaine on each side of cervical region at C5
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
Xylocaine
Intervention Description
10ml xylocaine on each side of cervical region at C5
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative rescue pethidine consumption
Description
in milligram
Time Frame
48 hours after operation
Secondary Outcome Measure Information:
Title
Postoperative visual analog pain score (VAS score)
Description
0 to 10 scale as 0: no pain and 10:worst degree of pain
Time Frame
4 hours postoperatively
Title
Postoperative visual analog pain score (VAS score)
Description
0 to 10 scale as 0: no pain and 10:worst degree of pain
Time Frame
8 hours postoperatively
Title
Postoperative visual analog pain score (VAS score)
Description
0 to 10 scale as 0: no pain and 10:worst degree of pain
Time Frame
12 hours postoperatively
Title
Postoperative visual analog pain score (VAS score)
Description
0 to 10 scale as 0: no pain and 10:worst degree of pain
Time Frame
24 hours postoperatively
Title
Postoperative visual analog pain score (VAS score)
Description
0 to 10 scale as 0: no pain and 10:worst degree of pain
Time Frame
48 hours postoperatively
Title
time to first rescue analgesic request
Description
in milligram
Time Frame
1 minute after requiring analgesics
Title
Intraoperative fentanyl consumption
Description
in microgram
Time Frame
1 minute after surgery.
Title
Occurrence of postoperative nausea
Description
yes or no
Time Frame
2 hours after operation
Title
Occurrence of postoperative vomiting
Description
yes or no
Time Frame
2 hours after operation
Title
Occurrence of postoperative pruritis
Description
yes or no
Time Frame
2 hours after operation
Other Pre-specified Outcome Measures:
Title
Age
Description
in years
Time Frame
1 hour preoperatively
Title
body mass index
Description
kg/m2
Time Frame
1 hour preoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Shawky, MD
Organizational Affiliation
Fayoum University
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University Hospital
City
Fayoum
State/Province
Faiyum
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28291143
Citation
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.
Results Reference
background
PubMed Identifier
30853517
Citation
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.
Results Reference
background
PubMed Identifier
18790686
Citation
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.
Results Reference
background

Learn more about this trial

Inter-semispinal Plane Block and Cervical Spine Surgery

We'll reach out to this number within 24 hrs