comparison between continuous infusion versus intermittent boluses of ropivacaine a local anaesthetic plus morphine in management of post operative pain after lower limb surgeries

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/11/029318
• Lead Sponsor: Yenepoya Medical college

Brief Summary

**Study Design**

Quasi experimental study.

**Materials and Methods**

After obtaining the Ethical committee clearance, preparation of all participants will be done including written informed consent. Then participants will be divided into two groups:

**Group IB        (intermittent bolus)**

**Group CI        (continuous infusion)**

**Source of data**

Patients in Yenepoya Medical College Hospital, Deralakatte, Mangalore who are admitted in Dept. of .ORTHOPEDICS during the period of August 2020 to September 2020 undergoing elective lower limb surgeries

**Sample Size :**The sample size is calculated using **G\* Power software .**

By considering level of significance at 10 % ( alpha = 0.10) and power 80 % with effect size 0.8(Standard Assumption) the total sample size in each group is 15 **. Total size - 30**

**a)****S****ampling technique :**Convenience sampling

**b)****Details of Clinical Examination**

Common procedure for both groups :

Patients (ASA classification 1 and 2) scheduled for elective lower limb surgeries will be counseled before surgery. In the operation theater, standard monitoring will be applied according to current ASA guidelines. Insertion of a lumbar epidural catheter (Perifix; B. Braun,) using a loss-of-resistance technique with Tuohy’s needle will be performed after skin disinfection in the sitting position at the L3-L4 or L2- L3 interspaces under mild sedation using 1-2 mg of intravenous (IV) midazolam. Following negative aspiration and negative response, a test dose of 3 mL of lidocaine 2% with epinephrine will be given. Spinal anaesthesia with Quincke’s 26G needle, following free flow of CSF,3 ml of 0.5% of hyperbaric bupivacaine will be injected into the sub arachnoid space. The indwelling catheter will be fixed using sterile dressing. After 5 min, cold/warm sensibility testing will be performed bilaterally to evaluate the appropriate spread. After surgery, patients will be transferred to the post-anaesthesia care unit (PACU)

Intervention in individual groups :

**Group CI:**

50cc Infusion syringe with infusion pump containing ropivacaine 0.1%/ml and Morphine 1mg ( total of  50ml ) will be connected to the epidural catheter. The pump will be programmed with a continuous infusion of 6 mL/h flow .

**Group IB**:

Intermittent bolus with ropivacaine 0.1% and Morphine 1mg ( total of  50ml ) ,6mL bolus will be  given every 60 min.

For both groups epidural analgesia will be started once the patient starts complaining of pain or VAS score more than 4 .

In case of insufficient analgesic response, controlled bolus injection of 4 mL (with lockout time: 30 min) will be given if the VAS score is more than 4. IV rescue analgesia with Inj tramadol 50 mg intravenously will be allowed as a ’rescue option’ for all participants in both groups.

As adverse effects there might be a fall in Blood pressure during epidural bolus injection which will be continuously monitored and taken care by immediately stopping the infusion or bolus and if required Inj Ephedrine 3mg iv is given to stabilize the BP . In very few patients there can be mild breathing difficulties which is temporary and very rarely needs support, otherwise no other adverse effects will be present.

The patients will be followed up at 12th& 24th hour interval. Pain assessment will be done by a 10 cm visual analogue scale (VAS); 0 no pain 10 worst imaginable pain. Change in heart rate and blood pressure will also be monitored. Patients will be reassessed and monitored for any side effects like nausea, vomiting, gastric irritation and respiratory depression every 30 minutes

**c)****Details of study like questionnaire**

Whether the participant is experiencing any pain postoperatively and rate the pain according to picture scale from 10 –1, heart rate and blood pressure monitoring

**d)****Validation of study tool (if applicable)****-----**Nil-----

**e)****Details of investigations (if any) and how the sample will be obtained and processed.****-----**Nil----

**Details of data tabulation and statistical analysis to be employed**

**Statistical analysis :**Descriptive statistics

**Independent sample t test/ mann whitney u test** will be employed to find out the mean difference in the analgesia achieved between 2 groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-25
• Study Completion: 2022-01-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients undergoing lower limb surgeries under spinal anaesthesia ASA grade  1&2.

Exclusion Criteria

Patient refusal Hemodynamic instability Patients with neuropathies Patients on chronic analgesic therapy Impaired higher mental function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intermittent boluses are similar to continuous infusion of epidural ropivacaine plus morphine for post operative analgesia.	12 hours 24 hours

Secondary Outcome Measures

Name	Time	Method
Early restoration and institution of physiotherapy

Trial Locations

Locations (1)

Yenepoya medical college; 🇮🇳 Kannada, KARNATAKA, India

Yenepoya medical college

🇮🇳Kannada, KARNATAKA, India

Avinash M

Principal investigator

9886186186

dravinashmunirathna@gmail.com