Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

Caudal Analgesia for Lumosacral Spine Surgeries Clinical Trial

Official title:

Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411329
• Other study ID #: R15/2020
• Status: Completed
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caudal Analgesia for Lumosacral Spine Surgeries

Intervention

Drug:
• Bupivacaine
local anesthetics, steriod, alpha 2 blockers
• Dexamethasone
dexamethazone
• Dexmedetomidine
dexmedetomidine
• Hyalouridinase
hyalouridinase

Locations

Country	Name	City	State
Egypt	Ainshams hospitals	Cairo
Egypt	Sanaa Farag Mahmoud	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of analgesia	time from second dose caudal epidural block to first analgesic requirement	postoerative 24 hours.
Secondary	postoperative pain	VAS score from zero for (no pain) till 10 for ( the most severe intractable pain)	postoperative 24 hours