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

Evaluation of Postoperative Analgesia with Intrathecal Morphine after Laparoscopic or Robotic Nephrectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033725

Enrollment

Registered

2021-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Intrathecal Morphine: Intrathecal Morphine-200 microgram+Bupivacaine Heavy 10 mg at Lumber (L) L2-3/L3-4 interspace Control Intervention1: Placebo: Skin over Lumber(L) L2-3/L3-4 intersp

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who will undergo elective laparoscopic or robotic radical nephrectomy 2.American society of Anaesthesiology Physical Score- I-III

Exclusion criteria

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 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 11. Coagulopathy (Platelet 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.

Design outcomes

Primary

Measure	Time frame
24 hours intravenous Morphine consumption in milligramTimepoint: At 24 hours from the end of surgery	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactAnshuman Sarkar

Tata Medical Center

anshudeep123@gmail.com9874035534

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026