A comparative study of two pain relief techniques - An injection at the back with morphine(drug for pain relief) versus an abdominal wall injection for donor nephrectomy(donor kidney removal) surgeries

A prospective, randomized, controlled, open labeled comparison of two analgesic techniques- Intrathecal morphine(ITM) and Transverse abdominis plane(TAP) block, for live laparoscopic donor nephrectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/07/007110

Enrollment

Registered

2016-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: GROUP M (INTRATHECAL MORPHINE): All the patients will receive an intrathecal injection of 5Âµg.kg-1 morphine in 1ml of normal saline in the left lateral position, using aseptic techniqu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consenting voluntary kidney donors scheduled for laparoscopic donor nephrectomy 2. Understanding spoken English/ Hindi 3. Controlled co-morbid conditions (ASA I-II)

Exclusion criteria

Exclusion criteria: 1. Refusal to participate 2. Pre-existing neuropathy 3. Morbid obesity 4. Contra indication to performance of spinal block, eg: local infection 5. Inability to understand spoken English/Hindi 6. Incapable of handling a PCA device 7. Known allergy to any of the study drugs 8. History of severe PONV or motion sickness 9. History of chronic analgesic use 10.Uncontrolled systemic disease 11.Symptomatic cardiac/respiratory disease

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of TAP block and intra-thecal morphine (ITM) for peri-operative analgesia in patients undergoing laparoscopic live donor nephrectomy compared to conventional analgesia by: 1. Peri operative fentanyl consumption 2. VAS scores at rest and on movement. Timepoint: 0,2,4,6,12 and 24 hours time points	—

Secondary

Measure	Time frame
1. To assess the effect of intra-thecal morphine and TAP block on recovery characteristics: a. Time to Readiness for discharge from PACU b. Time to ambulate c. Time to oral intake 2. To determine the incidence of adverse effects in all analgesic modalities: a. Respiratory depression b. Pruritus c. Nausea and vomiting (PONV) d. Catheter-related bladder discomfort (CRBD) Timepoint: TIME SCALES AS MINIMUM AS POSSIBLE	—

Measure

Time frame

1. To assess the effect of intra-thecal morphine and TAP block on recovery characteristics: a. Time to Readiness for discharge from PACU b. Time to ambulate c. Time to oral intake 2. To determine the incidence of adverse effects in all analgesic modalities: a. Respiratory depression b. Pruritus c. Nausea and vomiting (PONV) d. Catheter-related bladder discomfort (CRBD) Timepoint: TIME SCALES AS MINIMUM AS POSSIBLE

—

Countries

India

Contacts

Public ContactSATHIANARAYANAN SRINIVASAN

All India Institute of Medical Sciences

drsrajeshwari@gmail.com0919810079229

Outcome results