Evaluation of relief of pain in the postoperative period with spinal Morphine after laparoscopic or robotic kidney removal surgery

Phase 2

Completed

• Conditions: Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvisHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2021/05/033725
• Lead Sponsor: Anshuman Sarkar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

1. Patients who will undergo elective laparoscopic or robotic radical nephrectomy

2.American society of Anaesthesiology Physical Score- I-III

Exclusion Criteria

1. Emergency surgery

2. Conversion to open procedure

3. Contraindications to spinal anaesthesia (Paient refusal,spinal deformities,local site infection, severe aortic stenosis, increased intrcranial pressure)

4. Contraindications to study medication (allergy to Morphine, Bupivacaine)

5. Body mass Index more than 30 kg/m2 or those with documented obstructive sleep apnoea

6. Patients with life threatening arrhythmias

7. Patients with left ventricular ejection fraction <40%

8. Acute myocardial infarction (within 30 days)

9. Acute pulmonary edema (within 7 days)

10. Chronic obstructive pulmonary disease with a forced expiratory volume (FEV1) in the first second of expiration <50%

11. Coagulopathy (Platelet <1 lakh/cumm, APTT >2 times than control, INR >1.5)

12. Pre existing neurological illness (history of strokewithin last 6 months or with residual focal neurological deficits, history of low back pain with radiculopathy)

13. Significant liver dysfunction (liver enzymes >3 times of normal)

14. Significant renal dysfunction (Creatinine >2 times normal)

15. Psychiatric illness that will make the patient unable to understand numeric rating scale (NRS) or use of patient controlled analgesia pump (PCA)

16. Opioid abuse

17. Patient receiving systemic opioids for chronic pain

5.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hours intravenous Morphine consumption in milligramTimepoint: At 24 hours from the end of surgery

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl requirements <br/ ><br>1) Postoperative rescue fentanyl requirements in the first 48 hours <br/ ><br>2) Numeric Rating Scale (NRS) at rest <br/ ><br>3) Modified Ramsay Sedation Score <br/ ><br>4) NRS on first ambulation <br/ ><br>5) NRS on coughing <br/ ><br>6) Postoperative respiratory depression <br/ ><br>7) Time to enteric resumption <br/ ><br>8) Time to ambulation <br/ ><br>9) Time to flatus pass <br/ ><br>10) Postoperative nausea and vomiting <br/ ><br>11) Postoperative pruritus <br/ ><br>12) Patient satisfaction score <br/ ><br>13) Length of hospital stay <br/ ><br>Timepoint: on arrival at the ICU T0); 3 hours (T1);6hours (T2); <br/ ><br>12 hours (T3);24hours(T4) and 48 hours (T5)