| CTRI Number |
CTRI/2019/12/022389 [Registered on: 16/12/2019] Trial Registered Prospectively |
| Last Modified On: |
14/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs in post operative pain management in breast surgeries |
|
Scientific Title of Study
|
“COMPARATIVE EFFICACY OF LEVOBUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Rathod |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anesthesiology
Vijayangar institute of medical sciences,
Ballari 583 104
Bellary KARNATAKA 583 104 India |
| Phone |
9901170297 |
| Fax |
|
| Email |
krishnarathod114@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bala Subramanya H |
| Designation |
Professor |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anesthesiology
Vijayangar institute of medical sciences,
Ballari 583 104
Bellary KARNATAKA 583 104 India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krishna Rathod |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar institute of medical sciences, Ballari |
| Address |
Department of anesthesiology
Vijayangar institute of medical sciences,
Ballari 583 104
Bellary KARNATAKA 583 104 India |
| Phone |
9901170297 |
| Fax |
|
| Email |
krishnarathod114@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
Department of anesthesiology
Vijayangar institute of medical sciences,
Ballari 583 104 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Rathod |
Vijayangar institute of medical sciences, Ballari 583 104 |
Department of anesthesiology
Vijayangar institute of medical sciences,
Ballari 583 104 Bellary KARNATAKA |
9901170297
krishnarathod114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R20-R23||Symptoms and signs involving the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJ LEVOBUPIVACAINE BY ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK |
Single bolus dose of 30ml of 0.5% INJ LEVOBUPIVACAINE, IS ADMINISTERED BY ULTRASOUND GUIDANCE FOR SERRATUS ANTERIOR PLANE BLOCK, followed by general anaesthesia FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES |
| Comparator Agent |
INJ ROPIVACAINE BY ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK |
Single bolus dose of 30ml of 0.5% INJ ROPIVACAINE IS ADMINISTERED BY ULTRASOUND GUIDANCE FOR SERRATUS ANTERIOR PLANE BLOCK, followed by general anaesthesia FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status I & II patients
Female patients in the age group of 18 to 65 years.
Patients posted for elective unilateral breast surgeries with or without axillary clearance under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Refusal by patients for the block.
Surgery duration more than 2 hours.
History of significant systemic disorders (cardiovascular, respiratory,
central nervous system or renal system).
Infection at block site of block.
Thoracic wall and chest wall deformities.
Allergy to the study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia |
Study parameters are observed and recorded just before the administration of block, 5 minutes after administration, at the time of skin incision and every 10 minutes intra-operatively following the block till extubation and post-operatively at 5 min, 15min, 30min, then hourly for first 2 hours and at 4,6,12,24hrs after extubation. Post-operative pain will be assessed using visual analog scale (VAS) at rest and at coughing. Inj.tramadol 50 mg IV is used as rescue analgesic when VAS score is 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
the need for rescue analgesic,
total dose of rescue analgesic required,
perioperative haemodynamics
incidence of post-operative nausea and vomiting (PONV) and
adverse effects, if any. |
Up to 24hrs after extubation |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast cancer is increasingly becoming the most common cancer among the females in India. It accounts to around 25-32% of all female cancers in India as per National Cancer Registry1. Advances in Oncology has led to effective treatment in breast cancers. Breast cancers requires various surgical interventions like lumpectomy or mastectomy with axillary lymph node clearance. General anaesthesia is the conventional, most frequently used anaesthetic technique. Various regional anaesthetic techniques interventions have also been used for breast surgeries; these include local infiltration, thoracic epidural anaesthesia, thoracic paravertebral blocks, thoracic spinal anaesthesia, and more recently, ultrasound guided interfascial plane blocks such as Pectoral nerves ( PECS ), type 1 and type 2, Serratus anterior plane block. Although the beneficial effect of regional anaesthesia is well known, data are emerging for other potentially beneficial effects of regional anaesthesia and analgesia on other perioperative outcomes. Those include decreased need of opioid analgesics for post-operative pain management, decreased post-operative nausea and vomiting (PONV). Serratus anterior plane block was described by Fajardo as a new ultrasound guided technique. Local anaesthetic is injected between serratus anterior and external intercoastal muscles in the mid-axillary line to block the lateral cutaneous branches of the intercoastal nerves mainly from T2-T9 before dividing into anterior and posterior branches. On injection of local anesthetic at this level also blocks the thoracic and thoracodorsal nerves. The long-acting local anaesthetics viz., Ropivacaine and Levobupivacaine have been developed after the evidence of bupivacaine-related severe toxicity. Both these agents are pure left-isomers and, based on their three-dimensional structure; they have less toxic potential both on the central nervous system and on the heart. Although levobupivacaine is theoretically more potent than ropivacaine, clinical studies show conflicting results in terms of anesthetic and analgesic characteristics. Studies on various nerve blocks have shown that equipotent doses of ropivacaine and levobupivacaine have similar efficacy in peripheral nerve plexus blocks2. However, no study is available in the literature comparing the relative efficacy of these drugs in Serratus anterior plane block. This study is conducted to assess the comparative efficacy of Inj. Levobupivacaine and Inj. Ropivacaine in Serratus anterior plane block as a part of multimodal analgesia inpatients undergoing unilateral breast surgeries under general anaesthesia. |