| CTRI Number |
CTRI/2019/02/017467 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare injection of drugs (ketamine, levobupivacaine or a combination of both ketamine and levobupivacaine) given under the skin before the surgery for removing uterus in providing pain relief after surgery |
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Scientific Title of Study
|
COMPARISON OF KETAMINE, LEVOBUPIVACAINE AND A COMBINATION OF BOTH AS PRE-INCISION SURGICAL SITE INFILTRATION FOR POSTOPERATIVE ANALGESIA AFTER ABDOMINAL HYSTERECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUJ YADAV |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and
Safdarjung Hospital, Ansari Nagar, New Delhi-110029
South
South DELHI 110029 India |
| Phone |
9896907686 |
| Fax |
|
| Email |
anujyadav004@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parul Mullick |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and
Safdarjung Hospital,Ansari Nagar, New Delhi
South
DELHI
110029
South DELHI 110029 India |
| Phone |
9810606262 |
| Fax |
|
| Email |
parash93@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Parul Mullick |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and
Safdarjung Hospital,Ansari Nagar, New Delhi
South
DELHI
110029
South DELHI 110029 India |
| Phone |
9810606262 |
| Fax |
|
| Email |
parash93@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No funding, monetary or material support will be required. Study will be conducted in
Government hospital,VMMC and Safdarjung hospital. The hospital provides free treatment to
patients. |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and
Safdarjung Hospital,Ansari Nagar, New Delhi- 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuj Yadav |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Maternity Operation Theatre
Department of
Anaesthesia and
Intensive Care, VMMC
and Safdarjung
Hospital, Ansari Nagar South DELHI |
9896907686
anujyadav004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,VMMC &Safdarjung Hospital, New Delhi-110029 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine plus levobupivacaine
combination |
Patients will receive ketamine 1 mg/kg in levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. |
| Comparator Agent |
ketamine, levobupivacaine |
Patients will receive ketamine 1 mg/kg in saline, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.
Patients will receive levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling the American society of Anaesthesiologists (ASA) physical status I or II criteria,age from 18years to 75years,Duration of surgery less than 2 hours
|
|
| ExclusionCriteria |
| Details |
Patients with allergy to study drugs,cardiovascular disease (such as hypertension, tachycardia, arrhythmia, congestive heart failure, and coronary artery disease,Psychiatric disorder,Neurological disease, increased intracranial pressure, seizure disorder, glaucoma, hyperthyroidism
5. Liver or renal dysfunction.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| cumulative pethidine requirement in 24 h |
24 h after surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first pethidine requirement |
0 to 24h |
| cumulative pethidine requirement in 1, 2, 6, and 12 h time frame |
1, 2, 6, and 12 h after surgery |
| Pain scores at rest and on movement postoperatively at 0, 15 and 30 min and at 1, 2, 6, 12, and 24 h |
0, 15 and 30 min and at 1, 2, 6, 12, and 24 h after surgery |
| Occurrence of side effects such as nausea, vomiting, sedation and hallucinations |
0 to 24h |
| Patient satisfaction regarding postoperative analgesia at 24 h |
24h after surgery |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/03/2019 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Using a computer-generated random number table, patients will be allocated randomly into one of the three study groups: Group K: Patients will receive ketamine 1 mg/kg in saline, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. Group L: Patients will receive levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. Group KL: Patients will receive ketamine 1 mg/kg in levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. Group assignments will be concealed within opaque envelopes. PROCEDURE In the operating room, monitors (electrocardiogram, noninvasive blood pressure, pulse oximeter) will be applied and baseline readings noted. Anaesthesia will be induced with midazolam (1mg), fentanyl (2 µg/kg), propofol 10% (2 mg/kg) followed by vecuronium bromide (0.1 mg/kg) for facilitating insertion of Pro Seal laryngeal mask airway (PLMA). Anaesthesia will be maintained on oxygen and nitrous oxide (33:66) in isoflurane. Fentanyl (1µg/kg) bolus dose will be given at completion of one hour of anaesthesia induction, for meeting intraoperative analgesic requirement. Under strict aseptic precautions, after cleaning and draping the patient, the study drug will be infiltrated subcutaneously, in and around the incision line as a rectangle by the operating surgeon. The surgical incision will be given after 5 min have elapsed from the time of study drug administration. Approximately 30 min before the end of surgical procedure, 1 g paracetamol will be given intravenously over 15 min and 4mg ondansetron will be given intravenously over 5 min. At the end of surgery, volatile anaesthetics will be discontinued, residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg and the PLMA will be removed when the patient is fully conscious. Postoperatively, all patients will receive 1 g paracetamol intravenously 8 hourly for pain relief. If VAS score is ≥ 4, pethidine 0.4 mg/kg will be given intravenously, if the VAS score did not decrease within 10 more min, pethidine 0.2 mg/kg will be given to the patient with maximum dose of 1 mg/kg in any 4 h. The total pethidine consumption and time to the first additional pethidine need will be recorded. Finally, occurrence of adverse effects such as nausea, vomiting, sedation and hallucinations will be noted and treated accordingly. Following parameters will be noted on arrival of patient in the PACU at 0, 15 and 30 min, and at 1, 2, 6, 12, and 24 h postoperatively: Haemodynamic parameters and respiratory rate (RR) Severity of pain at rest and on movement using Visual Analogue Scale score (VAS) where 0 indicates no pain, and 10 is worst pain possible. Time to first pethidine requirement and cumulative pethidine requirement in 1, 2, 6, 12 and 24 h time frame. Occurrence of side effects such as nausea, vomiting, sedation, hallucinations. Occurrence and severity of nausea will be noted. Nausea severity will be graded as none/mild /moderate/severe. Retching will be considered as vomiting for statistical purpose. Level of sedation will be assessed using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation). Patient satisfaction from postoperative analgesia will be assessed at 24 h postoperatively using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied).
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