A comparison between two different drugs for spinal anaesthesia in knee surgery.

Completed

• Conditions: Patients with conditions (ACL/PCL tear/meniscus tear) that require arthroscopic knee surgery

• Registration Number: CTRI/2018/04/012976
• Lead Sponsor: Dr Suresh Kumar S

Brief Summary

**Background:** The primary goal of ambulatory anaesthesia is rapid recovery leading to early patient discharge with minimal side effects. Ropivacaine, due to its property of sensory-motor dissociation, may be a potentially useful agent when an equivalent spinal anaesthesia and quicker recovery of motor function is desirable. The main objective of our study was to compare 0.75% intrathecal isobaric ropivacaine (15mg) and 0.5% intrathecal isobaric bupivacaine (10mg) to assess the efficacy of anaesthesia, analgesia, postoperative recovery profile and readiness for discharge in patients undergoing arthroscopic knee surgery.

 **Materials and methods:** 90 adult ASA grade 1 and 2 patients were randomized into two groups to receive 2 ml plain solution of either 0.5% bupivacaine (Group B) or 0.75 % ropivacaine (Group R). In the intraoperative period, onset, efficacy, duration and regression of sensory and motor block were noted in both the groups at regular intervals. Postoperatively, the groups were compared for pain score using the visual analog scale (VAS), recovery profile using post anaesthetic discharge scoring system (PADSS), analgesic requirement and complications.

 **Results:**The mean time of onset of sensory block at L1 was significantly less (p=0.025) and duration of sensory (284.64 vs 257.57 mins) and motor block (250.07 vs 222.11 mins) was significantly more (p=0.001) with bupivacaine as compared to ropivacaine. Maximum upper level of sensory block was at T8 in both the groups, and the number of patients who attained this block was significantly more with bupivacaine (37.4% vs 22%, p=0.017). The number of patients who required 2 analgesic doses on the first postoperative day (33.3% vs 11.1%, p=0.011) and incidence of delayed voiding of urine (13.33% vs 0; p = 0.022) was significantly more with ropivacaine. There was no difference in postoperative recovery profile and discharge times between the groups.

 **Conclusions:** Isobaric bupivacaine provides a shorter onset and longer duration of sensory block, decreased postoperative analgesic requirement and lesser complication rate as compared with isobaric ropivacaine. Though, isobaric ropivacaine is associated with a shorter duration of motor block, postoperative recovery profile and discharge time between the groups was similar. Therefore, isobaric bupivacaine should be preferred over isobaric ropivacaine for day care knee arthroscopy, especially in cases with anticipated longer duration of surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-14
• Study Completion: 2010-09-22
• Last Update Posted: 2018-03-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1.Ninety adult patients scheduled to undergo elective knee arthroscopy.
• 2.Weight between 50-75 kg.
• 3.Height ranging from 150-180 cm.

Exclusion Criteria

• Patients who are unable to understand the procedure.
• Patients with refusal to spinal anaesthesia 3.
• Presence of local site infection.
• Patients with coagulation abnormalities.
• Patients with history of allergic reaction to any of the drugs.
• Patients with sepsis.
• Patients with spinal deformity or previous spinal surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To compare the efficacy and duration of motor block and sensory block between the two drugs.	1. Motor block was assessed by Modified Bromage Scale (1-6). Sensory block was assessed by loss of sensation to pin prick. Both the blocks were assessed every 2 minutes till two consecutive readings remained the same, after which it was assessed every 10 minutes till the end of surgery. After the surgery block was assessed half hourly till complete regression of block. | 2.Post operatively patients were assessed half hourly by Post Anaesthetic Discharge Scoring System until the score reaches 9.
2.To assess the post operative recovery profile and readiness for discharge in both the groups.	1. Motor block was assessed by Modified Bromage Scale (1-6). Sensory block was assessed by loss of sensation to pin prick. Both the blocks were assessed every 2 minutes till two consecutive readings remained the same, after which it was assessed every 10 minutes till the end of surgery. After the surgery block was assessed half hourly till complete regression of block. | 2.Post operatively patients were assessed half hourly by Post Anaesthetic Discharge Scoring System until the score reaches 9.

Secondary Outcome Measures

Name	Time	Method
Post operative pain and analgesia
Post operative complications such as pain, nausea, vomiting, headache, backache, hypotension, delayed voiding and transient neurologic symptoms.	All the patients were assessed after 24 hrs of surgery for post operative complications.

Trial Locations

Locations (1)

Vardhman Mahavir Medical college and Safdarjung hospital; 🇮🇳 Delhi, DELHI, India

Vardhman Mahavir Medical college and Safdarjung hospital

🇮🇳Delhi, DELHI, India

Dr Suresh Kumar S

Principal investigator

9999942084

surkum85@gmail.com