Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

NCT ID: NCT04411329

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-06
• Study Completion Date: 2021-05-06

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.

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Detailed Description

60 patient will be enrolled in the study. They will be allocated randomly into 3 groups. after induction of general anesthesia and changing the patient into prone position injection of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of the same mixture at the end of surgery) in all patients.

In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the second group we will add 50µg dexmedetomidine to the previous mixture given to the first group.

In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group

During the operation adjustment of sevoflurane concentration and fentanyl incremental doses (0.5 μg/kg) will be according to hemodynamic measurements.

Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the study.

In case of decrease in Blood Pressure greater than 20% from baseline, the patient will be infused by 500 ml ringer lactate and if blood pressure is not responding, administration of increments of 3 mg ephedrine will be given. Also If heart rate decreased to 45 beats/min, atropine sulfate 0.01 mg/kg will be given. Muscle paralysis will be antagonized by sugmmadex 2mg/kg at the end of surgery after switching the patient to the supine position.

Conditions

Caudal Analgesia for Lumosacral Spine Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group A

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

local anesthetics, steriod, alpha 2 blockers

Dexamethasone

Intervention Type: DRUG

dexamethazone

group B

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

local anesthetics, steriod, alpha 2 blockers

Dexamethasone

Intervention Type: DRUG

dexamethazone

Dexmedetomidine

Intervention Type: DRUG

dexmedetomidine

group c

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

local anesthetics, steriod, alpha 2 blockers

Dexamethasone

Intervention Type: DRUG

dexamethazone

Hyalouridinase

Intervention Type: DRUG

hyalouridinase

Interventions

Bupivacaine

local anesthetics, steriod, alpha 2 blockers

Intervention Type: DRUG

Dexamethasone

dexamethazone

Intervention Type: DRUG

Dexmedetomidine

dexmedetomidine

Intervention Type: DRUG

Hyalouridinase

hyalouridinase

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sanaa Farag Mahmoud Wasfy

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sanaa Farag Mahmoud

Cairo, New Cairo, Egypt

Ainshams hospitals

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 23362890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20512512 (View on PubMed)

Other Identifiers

R15/2020

Identifier Type: -

Identifier Source: org_study_id