Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

NCT04411329 | Completed

• 1 other identifier: R15/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine surgeries should be implemented to prevent CNS plasticity and to provide effective pain relief. The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. The most common way to provide pain management after spine surgery is the intravenous analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine, dexmedetomidine), or their combination. This study will compare adding different non opioid adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine surgery which can be a part of multimodal analgesia protocol. .

Conditions

Caudal Analgesia for Lumosacral Spine Surgeries

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

  time from second dose caudal epidural block to first analgesic requirement

  postoerative 24 hours.

Secondary Outcomes (1)

• postoperative pain

  postoperative 24 hours

Study Arms (3)

group A

ACTIVE COMPARATOR

patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery

Drug: Bupivacaine; Drug: Dexamethasone

group B

ACTIVE COMPARATOR

we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery

Drug: Bupivacaine; Drug: Dexamethasone; Drug: Dexmedetomidine

group c

ACTIVE COMPARATOR

we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery

Drug: Bupivacaine; Drug: Dexamethasone; Drug: Hyalouridinase

Interventions

Bupivacaine DRUG

local anesthetics, steriod, alpha 2 blockers

group A; group B; group c

Dexamethasone DRUG

dexamethazone

group A; group B; group c

Dexmedetomidine DRUG

dexmedetomidine

group B

Hyalouridinase DRUG

hyalouridinase

group c

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are aged from 18-65 years , ASA I and II, scheduled for lumbar spine surgery (laminectomy, discectomy, foraminotomy, fenestration or fusion) in a virgin back.

You may not qualify if:

• Patients with multiple level fixation, revision surgery, complicated spinal canal stenosis, traumatic lumbar surgeries were excluded, patients with addiction, allergy to local anesthetics or to any drug used in the study and those with coagulation abnormality are also excluded from the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Sanaa Farag Mahmoud

Cairo, New Cairo, 11835, Egypt

Location

Ainshams hospitals

Cairo, 11591, Egypt

Location

Related Publications (2)

• Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.

  PMID: 23362890 BACKGROUND

• Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.

  PMID: 20512512 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 2, 2020
• Study Start: June 6, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)