Isobaric levobupivacaine with or without clonidine for spinal anaesthesia

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/01/030367

Lead Sponsor: Guru Teg Bahadur Hospital

Brief Summary: Subarachnoid block will be given insitting position under all aseptic precautions at the level of L2-L3or L3-L4 intervertebral space as per the standardprotocol. Intrathecal drug will be given according to the group allotted asunder:

**Group-LC**:15 mg of 0.5% isobaric levobupivacaine (3ml) + 15Âµg of clonidine (0.15ml)

**Group-LS**: 15 mg of 0.5% isobaric levobupivacaine (3ml) + normalsaline (0.15ml)

The total volume of intrathecal drugwill be 3.15 ml in both the groups.

Block characteristics will be assessedusing loss of pinprick sensation for sensory block and Bromage Score for motorblock. Hemodynamic variables will also be recorded.

Statistical analysis will be carriedout in SPSS, software version 20.0 or latest. The quantitative parameters likeage, height, weight, time of onset of block (when the sensory block is achievedat level of T10 dermatome), maximum height of sensory blockachieved, duration of effective analgesia (time from giving subarachnoid blockto patientâ€™s first complaint of pain (VAS â‰¥ 3) and rescue analgesia given topatient which are recorded at onetime point will be compared usingunpaired t-test. Qualitative data likegender distribution, ASA physical status, quality of muscle relaxation,intensity of motor block and VAS score will be analysed using the Chi-squaretest or Fisherâ€™s exact test whichever is applicable. Repeated measures ANOVAwill be used to compare the hemodynamic variables. A p-value < 0.05 will beconsidered significant.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

ASA grade I or II between 18-65 years height 150-180 cm.

Exclusion Criteria

â€¢Patients who do not give consent for subarachnoid block.
Patients with contraindication to subarachnoid block: infection at injection site, coagulopathy, space-occupying lesion, increased intracranial tension, known case of seizure disorder, pre-existing neurological deficit, and spine deformity.
History of allergy to any drug being used in the study.
Pregnant patients.
Known case of hepatic and renal disease, drug addicts and chronic alcoholics.
Patients who are on antiarrhythmic drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of effective analgesia	ONce \| Time from the subarachnoid block to the time of patientâ€™s first complaint of pain and VAS more than 3

Secondary Outcome Measures

Name	Time	Method
Sensory and motor block charactersitics	every 2 min for the first 10 min and then every 5 min till the same level is obtained in 3 consecutive readings

Trial Locations

Locations (1): Guru Teg Bahadur Hospital
🇮🇳
East, DELHI, India
Guru Teg Bahadur Hospital
🇮🇳East, DELHI, India
Dr RS Rautela
Principal investigator
9625900699
rsramb@gmail.com