Evaluation of analgesic efficacy of intrathecal neostigmine added to bupivacaine in Patients undergoing lower limb orthopedic surgery

The effects of intrathecal neostigmine added to bupivacaine on postoperative analgesic requirement in Patients undergoing lower limb orthopedic surgery

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000908730

Enrollment

Registered

2013-08-14

Start date

2013-08-01

Completion date

2013-10-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Objective : To evaluate the analgesic efficacy of neostigmine as an additive to intrathecal bupivacaine. Methods: Following Ethics Committee approval and informed patients consent, Sixty patients 18-80 yr old ASA physical status I or II, scheduled for lower limb surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of two groups of 30 each. The neostigmine group (group N) received bupivacaine 20 mg combined with 25microgram 0.5ml neostigmine and the placebo group (group P) received bupivacaine 20 mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement , postoperative analgesic requirements duration of sensory and motor blockade, hemodynamics variables, and Adverse events such as hypoxia (oxygen (SpO2)<90], bradycardia hypotension, postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, pethidine 25 mg intravenously , was to be given for post-operative pain relief as needed .

Interventions

Sixty patients 18-80 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of two groups of 30 each. The neostigmine group (groupN received bupivacaine 20mg combined with 25 microgram neostigmin ,and The placebo group (group P) received bupivacaine 20 mg combined with 0.5ml distilled water(intrathecally) for each

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients with American Society of Anesthesiologists(ASA) physical status I and II undergoing elective lower limb surgery

Exclusion criteria

significant coexisting disease such as hepato-renal and cardiovascular disease, any contraindication to regional anesthesia such as local infection or bleeding disorders, allergy , long-term opioid use or a history of chronic pain.

Outcome results