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

Phase 1

Completed

• Conditions: post-operative pain inPatients undergoing lower limb orthopedic surgery; post-operative pain in; Patients undergoing lower limb orthopedic surgery; Anaesthesiology - Anaesthetics; Surgery - Surgical techniques

• Registration Number: ACTRN12613000908730
• Lead Sponsor: Qazvin Medical Science University

Brief Summary

Patients receiving neostigmine had a significantly prolonged duration of motor block compared to the control group. The difference of the mean time to the first analgesic request was also significantly longer in neostigmine group The total analgesic consumption during the first 12 hours after surgery was devoid of any significant difference between groups N and C .The two groups were not significantly different in terms of intraoperative and postoperative side effects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Study Completion: 2013-10-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)[Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution]; Duration of Sensory block will be assessed by a pinprick test<br>[The duration of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the reappearance of sensation at the T10 dermatome(sensory block will be assessed by pinprick test every 5minutes following intrathecal injection]; Duration of motor block (the time from intrathecal injection to Bromage score 0 will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)<br>[The time from intrathecal injection to Bromage score 0( motor block will be assessed by the modified Bromage score every 5 minuts following intrathecal injection)]

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure is assessed by nonivasive automatic blood pressure measurement<br>[ 5min before the intrathecal injection,and at 2, 4, 6,8, 10, 15,20 min after the injection]; Adverse effects such as vomiting,pruritus[the time from intrathecal injection to 12 hours later]