To compare the pain relief in spine surgery from two pain killer drugs (Bupivacaine and Morphine) delivered regionally around spinal cord using ultrasound guidance.

Completed

• Conditions: Patients undergoing lumbosacralspine surgeries

• Registration Number: CTRI/2017/11/010581
• Lead Sponsor: AIIMS

Brief Summary

After obtaining institutional ethics committee approval, 40 patientsscheduled for lumbosacral spine surgery will be included in the study. **Preanaestheticcheckup:**

A detailed preoperative evaluation will be done including details and durationof disease, traumatic or degenerative cause , treatment taken, duration oftreatment, and dose of preoperativeanalgesics for pain relief.

Routine investigations,Coagulation profile , ECG and Chest x ray will be performed.

Patients will be briefed about the PCA (Patient Controlled Analgesia)device to be used postoperatively and patient dexterity with the device will beensured.

Visual analog scale will also be explained.

Patients will receive standardpremedication with T.Alprazolam 0.5mg at night prior to day of surgery and twohours before surgery.

**Anaesthesia technique:**

After mid nightfasting, patient**,** in operating roomperipheral venous access will be placed. Standard intraoperative monitoring with ECG,  SpO2,  NIBP,  EtCO2 will be instituted.

Afterpreoxygenation, anaesthesiawill be induced with Inj. Propofol  2-3mg/kgi.v , Inj. Fentanyl  2µg/kg i.v. , andInj. Atracurium followed by endotracheal intubation. Anaesthesiawill be maintained with Oxygen : N2O (50 : 50) andIsoflurane ( MAC 0.8  -1).

I.V. fluids willbe administered as per the requirement. Intra operative monitoring will includeECG, EtCO2, anesthetic gases, SpO2 , NIBP, and blood loss.

 Following prone positioning, the patients will be randomly dividedinto two groups using computer generated randomisation.

One group will receive ultrasound guided caudal epidural blockwith  morphine 50 µg/kg diluted with 20ml of 0.25% bupivacaine. Second group will receive ultrasound guided caudalepidural block with 0.25% bupivacaine alone. The block will be administeredusing 18 gauge tuohy needle.

 Tranexamic acid (bolus 10 mg/kg followed by 1mg/kg/hour infusion) willbe given to reduce perioperative blood loss.

Rescue boluses of fentanyl0.5-1 µg/kg, will be given if there is an increase in the heart rate or bloodpressure more than 20% of the baseline after ensuring adequate depth ofanaesthesia and normovolemia.

 Thirty minutes prior to extubation, injection Ondansetron (4mg) willbe given to prevent postoperative nausea and vomiting . Afterthe completion of surgery neuromuscularblock will be reversed with Inj. neostigmine 40-70mcg/kg and Inj.glycopyrrolate7-10mcg/kg. Trachea will be extubated when patient fulfills the clinicalcriteria(regular breathing, respiratory rate>10 and <30 and tidalvolume> 5-6 ml/kg).

 **Postoperative Management and assessment**

Postoperatively patients will be shifted from Operation room toRecovery room (PACU).  PCA device will beattached and patient instructed to take boluses on demand as soon as cognitivefunction recovers. Each bolus will deliver 1mg morphine, with a lockout periodof 10 minutes. No basal infusion will be provided. Paracetamol 1g intravenousinfusion (20mg/kg for smaller patients) 8 hourly will be continued for 24hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-23
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients, aged between 18-60 years, undergoing lumbosacral spine surgery ( trauma and degenerative) will be included in the study.
• Patients willing to give consent .

Exclusion Criteria

• Patient refusal 2.
• Patients with head injury or raised intracranial pressure.
• Patents with coagulopathy.
• Patients with infection at the local site.
• Patients with allergy to the local anaesthetic drug.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time to first activation of PCA	VAS – Immediate postoperative period, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
2.Total Morphine consumption	VAS – Immediate postoperative period, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
3. VAS	VAS – Immediate postoperative period, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours

Secondary Outcome Measures

Name	Time	Method
1.Total intraoperative fentanyl requirement	2. Incidence of Adverse effects.

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Ansari Nagar, New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences, Ansari Nagar, New Delhi

🇮🇳South, DELHI, India

Dr Amit Kumar Malviya

Principal investigator

09981319419

amit2411@gmail.com