To compare the outcome of two spinal drugs on patients in Percutaneous Nephrolithotomy

Recruiting

Conditions: Calculus of kidney,

Registration Number: CTRI/2023/07/054971

Lead Sponsor: North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)

Brief Summary: Thisprospective randomized study will be conducted on patients undergoing PCNLunder spinal anaesthesia (SA). Patients will be randomized by simple randomsampling into two groups, n=40, after verifying the inclusion an exclusioncriteria. This study will compare the onset, duration and intensity of SA,duration of postoperative pain relief as well as intraoperative hemodynamicchanges and incidence of complications when either hyperbaric ropivacaine 0.75%or hyperbaric bupivacaine 0.5% is combined with 2mg nalbuphine in spinalanaesthesia used for PCNL. This study will guide to select better drugcombination and drug profile for PCNL which will be beneficial to the patient.With the use of either ropivacaine with nalbuphine or bupivacaine withnalbuphine in SAB for PCNL, it is expected to have hemodynamic stability,decrease complications, decrease PONV, decrease post-operative pain and alsodecrease length of hospital stay.

Oncepatient is shifted to the operating room, ASA standard monitor will beconnected and baseline BP, HR, Sp02 will recorded and monitored throughout theprocedure. Both groups will receive SA in sitting position in L2-L3intervertebral space using 27G Quincke spinal needle.

Group-R(n=40):Ropivacaine group=3.2 ml 0.75% Ropivacaine (heavy) + 2mg Nalbuphine

Group-B(n=40):Bupivacaine group=3.2 ml 0.5% Bupivacaine (heavy) + 2mg Nalbuphine

Sensoryblockade will be evaluated every 30 seconds and motor blockade will be assessedby Modified Bromage scale till the block height of T6 is attained.

Allpatients will be monitored with non-invasive multiparameters (SBP, DBP, MAP,HR) every two minutes for the first 10 minutes than every five minutes duringand till the end of the surgery and every 20 minutes in the Post-AnaestheticCare Unit (PACU).

Patientswill be observed for 24 hrs for pain with NRS scoring (0-10, 0=No pain &10= Worst pain).

Patientswill be also observed and noted for any postoperative complications like nausea,vomiting, hypotension (SBPâ‰¤ 90mmhg), bradycardia (PRâ‰¤ 60/min), back pain and posturalheadache. The complications will be treated with appropriate measures.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients undergoing elective PCNL ASA physical status I & II.

Exclusion Criteria

Patientâ€™s refusal Patient with known allergy to the drugs used in the study Hemodynamic instability.
Coagulopathy Patients with significant cardiac, respiratory and hepatic dysfunction â€¢Spinal deformity â€¢Local infection at injection site.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the onset, duration and intensity of spinal anaesthesia as well as duration of postoperative pain relief.	Intraoperative and 24hrs postoperative

Secondary Outcome Measures

Name	Time	Method
Intraoperative hemodynamic changes and incidence of complications.	Intra-operative

Trial Locations

Locations (1): North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences(NEIGRIHMS) Hospital
🇮🇳
Hills, MEGHALAYA, India
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences(NEIGRIHMS) Hospital
🇮🇳Hills, MEGHALAYA, India
DrPriyanka Dev
Principal investigator
07577055859
Priyanka8ap@gmail.com