| Literature DB >> 34764504 |
Sadhana Sudhir Kulkarni1, Deepak Narayan Tayade2, Mukund Kachru Parchandekar3, Prabha Pandurang Nayak4, Vasanti Prabhakar Kelkar4, Prashant Jangonda Pachore3.
Abstract
BACKGROUND AND AIMS: Incidence of major neurological complications following central neuraxial blockade (CNB) in India is not known. This information is essential for explaining risk preoperatively to patients and for medico-legal purposes. This study was undertaken to assess feasibility (recruitment process, protocol adherence, resources mobilisation, data management and evaluation of scientific outcome) for planning multicentric studies on major neurological complications following CNB at state/national level.Entities:
Keywords: Complications; feasibility study; multicentre study; neuraxial anaesthesia; neurological manifestations; pilot study
Year: 2021 PMID: 34764504 PMCID: PMC8577715 DOI: 10.4103/ija.ija_639_21
Source DB: PubMed Journal: Indian J Anaesth ISSN: 0019-5049
Figure 1Flow chart of patients through the pilot study
Feasibility Criteria and Feasibility of a Large Scale Study
| Feasibility criteria | Expected | Results of the pilot study | Large scale study Feasibility |
|---|---|---|---|
| 1 Recruitment | |||
| Participation of Institutes/Anaesthesiologists | 70% | 100% TCI* and 76.41% | Feasible |
| Recruitment of eligible patients | 70% | 99.98% | Feasible |
| 2 Data Management | |||
| Complete Data uploading | 90% | 100% | Feasible with timely reminders |
| Data uploading was user friendly | 90% | 97.3% | Feasible |
| Time taken for uploading information/patient | 3 minutes‡ | 3-5 min. Time consuming for large data of TCI | Feasible. Data entry operator is needed for TCI |
| Data uploading complications, analysis and follow-up | Reporting 100%, follow-up 90% patients | 100% | Feasible |
| 3 Resources | |||
| Financial and infrastructure resources | Funds for computer and payment for Data operator may not be generated for a pilot study. | Financial aid Feasible | Feasible |
| Additional Human Resources | Coordinators and Different study committee members are essential. | Teamwork and | Feasible |
| 4. Management | |||
| Participants (Anaesthesiologists) | 90% of anaesthesiologists will upload data | 97.3%, Contribution of Anaesthesiologists practicing Super speciality was less | Feasible |
| Reporting complications by participants, follow-up and analysis, | Skeptical about complication reporting and analysis with online tools. | All patients developing | Feasible (complication reporting, follow-up and Analysis) |
| 5. Scientific Outcome | |||
| Adequacy of data collection and analysis | Skeptical about collecting sufficient evidence to demonstrate the feasibility and cause-effect relationship of CNB complication | Data of 8053 patients’ | Large scale study is Feasible |
*TCI: Tertiary care institutes, †NTCI: Non-tertiary care institutes, ‡This was an observation of the protocol review committee, CNB: Central neuraxial block
Demographic Data of Patients
| Age Group Years | Female (Number of patients) | Male (Number of patients) | Total number and % of Patients | ||||
|---|---|---|---|---|---|---|---|
|
|
| ||||||
| TCI | NTCI | Total | TCI | NTCI | Total | ||
| 0-10 | 6 | 4 | 10 | 12 | 25 | 37 | 47 (0.58%) |
| 11-20 | 626 | 66 | 692 | 225 | 48 | 273 | 965 (11.98%) |
| 21-30 | 2315 | 852 | 3167 | 416 | 105 | 521 | 3688 (45.79%) |
| 31-40 | 389 | 280 | 669 | 413 | 111 | 524 | 1193 (14.81%) |
| 41-50 | 177 | 88 | 265 | 333 | 101 | 434 | 699 (8.6%) |
| 51-60 | 120 | 38 | 158 | 266 | 93 | 359 | 517 (6.41%) |
| 61-70 | 141 | 41 | 182 | 332 | 95 | 427 | 609 (8.67%) |
| Above 70 | 67 | 22 | 89 | 159 | 87 | 246 | 335 (4.15%) |
| Total (%) | 3841 (47.69%) | 1391 (17.27%) | 5232 (64.96%) | 2160 (26.82%) | 661 (8.22%) | 2821 (35.04%) | 8053 (100.00%) |
TCI: Tertiary care institutes, NTCI: Non-tertiary care institutes
Age Group and Type of CNB
| Age Group | Caudal Anaesthesia | Epidural Anaesthesia | Spinal Anaesthesia | Combined Spinal Epidural Anaesthesia | Total Number (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
| ||||||||||
| TCI | NTCI | Total | TCI | NTCI | Total | TCI | NTCI | Total | TCI | NTCI | Total | ||
| 0-10 | 0 | 14 | 14 | 0 | 0 | 0 | 22 | 11 | 33 | 0 | 0 | 0 | 47 (0.58) |
| 11-20 | 0 | 0 | 0 | 6 | 3 | 9 | 817 | 111 | 928 | 28 | 0 | 28 | 965 (11.98) |
| 21-30 | 0 | 0 | 0 | 14 | 30 | 44 | 2655 | 926 | 3581 | 62 | 1 | 63 | 3688 (45.80) |
| 31-40 | 0 | 0 | 0 | 11 | 2 | 13 | 700 | 387 | 1087 | 91 | 2 | 93 | 1193 (14.81) |
| 41-50 | 0 | 0 | 0 | 9 | 3 | 12 | 435 | 181 | 616 | 66 | 5 | 71 | 699 (8.68) |
| 51-60 | 0 | 0 | 0 | 4 | 3 | 7 | 339 | 123 | 462 | 43 | 5 | 48 | 517 (6.41) |
| 61-70 | 0 | 0 | 0 | 7 | 2 | 9 | 394 | 129 | 523 | 72 | 5 | 77 | 609 (7.56) |
| Above 70 | 0 | 0 | 0 | 9 | 1 | 10 | 188 | 104 | 292 | 29 | 4 | 33 | 335 (4.15) |
| Total (%) | 0 | 14 (0.17%) | 14 (0.17%) | 60 (0.74%) | 44 (0.54%) | 104 (1.30%) | 5550 (68.91%) | 1972 (24.48%) | 7522 (93.41%) | 391 (4.85%) | 22 (0.27%) | 413 (5.12) | 8053 (100%) |
TCI: Tertiary care institutes, NTCI: Non-tertiary care institutes, CNB: Central neuraxial block
Local Anaesthetic Agents used in Tertiary Care Institutes and Non-Tertiary Care Institutes*
| Local Anaesthetic | TCI (No. of patients) | NTCI (No. of patients) | Total (No. of patients) |
|---|---|---|---|
| Bupivacaine | 5702 (70.80%) | 1991 (24.72%) | 7693 (95.53%) |
| Bupivacaine and lignocaine | 273 (3.39%) | 30 (0.37%) | 303 (3.77%) |
| Lignocaine (5% Hyperbaric) | 13 (0.16%) | 14 (0.17%) | 27 (0.33%) |
| Chloroprocaine | 1 (0.012%) | 10 (0.12%) | 11 (0.13%) |
| L-Bupivacaine | 8 (0.099%) | 6 (0.074%) | 14 (0.19%) |
| Ropivacaine | 3 (0.037%) | 1 (0.012%) | 4 (0.050%) |
| L-Bupivacaine and lignocaine | 1 (0.012%) | 0 (0%) | 1 (0.012%) |
| Total no. of Patients | 6001 (74.52%) | 2052 (25.48%) | 8053 (100%) |
*Percentages were calculated column-wise. TCI: Tertiary care institutes, NTCI: Non-tertiary care institutes
Major neurological complications analysed by the Audit Committee
| Complication observed | *Cause and effect relation with CNB | Measures suggested for prevention |
|---|---|---|
| Cardiac arrest after repeat spinal anaesthesia | Event: Total spinal anaesthesia resulted after repeat spinal anaesthesia as dose of local anaesthetic exceeded the recommended dose. There was delay in recognition of total spinal anaesthesia. | Possibility of total spinal anaesthesia after repeat spinal anaesthesia should be anticipated. Early recognition of total spinal anaesthesia by continuous and vigilant monitoring of vital signs including altered consciousness and immediate treatment with head-low position, administration of fluids and vasopressors along with ventilation with 100% Oxygen can prevent cardiac arrest |
| Cardiac arrest after combined Spinal- epidural anaesthesia (ASA II)* | Event: Large epidural bolus dose of local anaesthetic for maintenance of anaesthesia during combined spinal- epidural anaesthesia was responsible for severe hypotension. Adequacy of oxygenation could not be assessed in the patient in lateral position. Pulse Oximeter readings were not of help due to hypotension. Patient had cardiac arrest. | Titrate level of the block by giving small incremental doses of epidural rather than administering a large bolus during maintenance with epidural anaesthesia during combined spinal-epidural block. Immediate treatment with vasopressors, fluids and adequate oxygenation can be life saving |
CNB: Central neuraxial blockade, ASA: American Society of Anaesthesiologists * This patient (52 years) had a well controlled hypertension and was receiving atenolol 50 mg and amlodipine 5 mg BD. Electrocardiogram and Echocardiogram of the patient were normal
Advisors:
| Name | Designation | Institute |
|---|---|---|
| Dr. Mohan | Director, Post Graduate | Muljibhai Patel |
| Dr. Nithya | Professor, Department of | Seth GS Medical College and KEM |
| Dr. Sudhir | Professor and Head, | MGM Medical |
| Dr. Avinash Ratnaparkhi | Consultant in Intensive Care | Darlington Memorial |
| Adv. Sanjay Hivarekar | Senior Advocate | High Court, |
Protocol Evaluation Committee Members:
| Name of expert | Designation | Institute |
|---|---|---|
| Dr. Shobhana J. | Professor, | P. Vikhe Patil Medical |
| Dr. Seema A. | Senior | Dr. Hedgewar Hospital, |
| Dr. Renu M. | Senior | Dr. Hedgewar Hospital, |
| Dr. Pramod V. | Professor, | MGM Medical College, |
| Dr. Shubhada A. | Assoc. Professor, | IIMSR, Badnapur, Jalna |
| Dr. Madhuri P. | Assoc. Professor, | IIMSR, Badnapur, Jalna |
| Dr. Sonal A. | Assoc. Professor, | Govt. Medical College |
Study Coordinators:
| Name | Designation | Institute |
|---|---|---|
| Dr. Prabha | Professor of | MGM Medical College and Hospital, Aurangabad |
| Dr. Samiksha | Clinical Assistant, | MGM Medical College and Hospital, Aurangabad |
| Dr. Yashoda | Clinical Assistant, | MGM Medical College and Hospital, Aurangabad |
Audit Committee Members:
| Name | Designation | Institute |
|---|---|---|
| Dr. Sudhir W. | Professor & Head, | IIMSR, Badnapur, Jalna |
| Dr Unmesh V. | Director and | United CIIGMA Hospital, |
| Dr. Makarand | Chief Neurologist | Manik Hospital & Research |
| Dr. Deepak S. | Professor & Head, | MGM Medical College, |
| Dr. Surekha | Professor & Head, | Govt. Medical College |
| Dr Ishtyaque | Professor of | MGM Medical College, |
| Dr. Shubhangi | Senior Radiologist | Mangal Medi Centre, |
Adjudication Committee Members:
| Name | Designation | Institute |
|---|---|---|
| Dr. Anirudha | Professor, Dermatology | MGM Medical |
| Dr. Sachin | Professor and Head, | MGM Medical |
| Dr. Sangita | Professor, Physiology | MGM Medical |
| Dr. Deepali | Professor, Biochemistry | MGM Medical |
| Dr. Bhavna | Assistant Professor, Community Medicine | MGM Medical |
Study Assistant:
| Name | Designation | Institute |
|---|---|---|
| Mr. Syed | Sr. Clerk, Department of | MGM Medical College and Hospital, Aurangabad |
Indications of Central Neuraxial Blocks
| Type | TCI | NTCI | Number of patients | Percentage of patients* |
|---|---|---|---|---|
| Perioperative CNB | 5825 | 1715 | 7540 | 93.63% |
| Obstetric analgesia | 90 | 69 | 159 | 1.97% |
| Obstetric analgesia and anaesthesia | 78 | 264 | 342 | 4.24% |
| Chronic pain management | 8 | 4 | 12 | 0.13% |
| Total | 6001 | 2052 | 8053 | 100% |
*Percentages are calculated column-wise.
Adjuvant used during CNB
| Adjuvant used with Local Anesthetic | TCI | NTCI | Total number of patients | Total percentage of patients |
|---|---|---|---|---|
| Not received any adjuvant | 4624 | 1730 | 6353 | 78.88% |
| Fentanyl | 1082 | 253 | 1335 | 16.5% |
| Clonidine | 260 | 46 | 306 | 3.9% |
| Buprenorphine | 29 | 23 | 52 | 0.65% |
| Adrenaline | 3 | 0 | 3 | 0.037% |
| Triamcinolone* | 3 | 0 | 4 | 0.037% |
| Total | 6001 | 2052 | 8053 | 100% |
*Triamcinolone was used with Bupivacaine for Chronic backache management