| CTRI Number |
CTRI/2018/04/013124 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative pain management in breast cancer surgery |
|
Scientific Title of Study
|
Comparison of effects of intraoperative infusion of low dose ketamine versus lignocaine in post operative pain management in patients undergoing breast cancer surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Midhun Baby |
| Designation |
junior resident |
| Affiliation |
Govt medical college-Kozhikode |
| Address |
Dept of Anaesthesia,
Govt medical college-Kozhikode
kerala Thenasseril house
Chettapalam PO
Pulpally,
Wayanad Kozhikode KERALA 673008 India |
| Phone |
9400640729 |
| Fax |
|
| Email |
midhun.ann89@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suvarna K |
| Designation |
Additional professor of Anaesthesia |
| Affiliation |
Govt medical college- Kozhikode |
| Address |
Dept of Anaesthesia,
Govt medical college-Kozhikode, Kerala,
India Kaniyil house,
kaviyoor, Chokli. P.O
kannur district
kerala Kozhikode KERALA 673008 India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suvarna K |
| Designation |
Additional professor of Anaesthesia |
| Affiliation |
Govt medical college- Kozhikode |
| Address |
Dept of Anaesthesia,
Govt medical college-Kozhikode, Kerala,
India Kaniyil house,
kaviyoor, Chokli. P.O
kannur district
kerala Kozhikode KERALA 673008 India |
| Phone |
9447638221 |
| Fax |
|
| Email |
suvarnakaniyil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Govt medical college-Kozhikode |
|
|
Primary Sponsor
|
| Name |
Govt medical collegeKozhikode |
| Address |
Dept of Anaesthesia,
Govt medical college-Kozhikode
kerala |
| 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 Midhun Baby |
Govt medical college-Kozhikode, Kerala |
Dept of Anaesthesia- Major operation theatre comlex, Govt medical college-Kozhikode, Kerala Kozhikode KERALA |
9400640729
midhun.ann89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Govt medical college-Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, patients with carcinoma breast sheduled for modified radical mastectomy who comes under American society of Anaesthesiologists physical status I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine group |
After general anaesthesia induction and intubation the study drugs are given before skin incision. In Ketamine group injection ketamine 0.2mg/kg bolus given intravenously before skin incision and followed by infusion of 0.2mg/kg/hr till the end of the surgery |
| Intervention |
Lignocaine infusion |
patients with carcinoma breast sheduled for elective modified radical mastectomy were randomly divided into two groups of 25 each. After general anaesthesia induction and intubation the study drugs are given before skin incision. The Lignocaine group received intravenous bolus dose of 2mg/kg preservative free Lignocaine followed by infusion at a rate of 2mg/kg/hr till the end of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female carcinoma breast sheduled for modified radical mastectomy
2. Age 30-65 yrs
3. American society of physical status I and II
3. weight 40-70kg
|
|
| ExclusionCriteria |
| Details |
1. patients with chronic pain /on chronic analgesics or opioid
2. Patient refusal
3. Drug allergy
4. pregnancy
|
|
|
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 |
1. Duration of postoperative analgesia
2. Total analgesic consumption in first 24 hours |
1. Duration of postoperative analgesia from end of surgical closure of wound
2. Total analgesic consumption in first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. sedation score after extubation
2. Chronic post surgical pain persisting after 3 months
|
1. sedation score is noted just after extubation and 30 minutes after extubation
2. Chronic pain is assessed 3months after surgery . |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2017 |
| Date of Study Completion (India) |
12/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1.60. Grigoras A, Lee P, Sattar F, Shorten G. Perioperative intravenous lidocaine decreases the incidence of persistent pain after breast surgery. Clin J Pain. 2012 Sep 1;28(7):567-72.
2. 66. Behdad A, Hosseinpour M, Khorasani P. Preemptive use of ketamine on post operative pain of appendectomy. Korean JPain. 2011 Sep 1;24(3):137-40.
3. 68. Jendoubi A, Naceur IB, Bouzouita A, Trifa M, Ghedira S, Chebil M, Houissa
M. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study. Saudi J Anaesth. 2017 Apr;11(2):177.
4. 72. Mahran E, Hassan ME. Comparison of pregabalin versus ketamine in postoperative pain management in breast cancer surgery. Saudi J Anaesth. 2015 Jul;9(3):253.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast
cancer surgery is a common surgery with many of the patients experiencing
moderate to severe pain, both acute and chronic postsurgical pain in the postoperative period. One of the modalities for
management of postsurgical pain in breast cancer surgery is opioids but increasing no of recent reports regarding early reccurence of ma;ignancy with opioid usage is alarming. Opioids
are also associated with several adverse effects such as itching, postoperative
nausea and vomiting, respiratory depression, etc. Concerns about opioid risk in
the postoperative period has aroused an increased interest in the use of
non-opioid analgesic adjuvants. Intravenous lignocaine and low dose ketamine
infusions have individually shown to reduce the opioid consumption and to
improve the overall postoperative outcomes in several studies. There is a
paucity of literature comparing the efficacy of these two drugs. So, we did this
study to compare the efficacy and duration of analgesia and development of chronic pain with use of intravenous
lignocaine and low dose ketamine in breast cancer surgery. This will help us
find out a superior technique with effective analgesia that will be very
helpful to control pain and prevent its complication in many of the patients
undergoing breast surgery.
Study was conducted on 60 patients undergoing
mastectomy after getting approval from Ethical committee and consent. Patients were randomised to two groups of 30 each. Preoperatively, all patients were instructed regarding
how to read the Numerical Rating Scale used for assessing
the pain in the postoperative period. Premedication was with oral ranitidine
150 mg and metoclopramide 10 mg on the previous night of surgery and on the
morning of surgery.
On arrival to the operation theatre, standard monitors were attached and baseline parameters were
recorded. Each patient received iv glycopyrrolate 10 mcg/kg, iv ondansetron 0.1
mg/kg, iv midazolam 0.01mg/kg and iv fentanyl 2 mcg/kg. After pre-oxygenation for three minutes, patients were
induced with Inj. Propofol 2mg/kg. Endotracheal intubation with appropriate
sized, cuffed endotracheal tube was facilitated with Inj. Succinylcholine 1.5
mg/kg. Anesthesia was maintained with nitrous oxide, oxygen and Isoflurane and Inj.
Vecuronium bromide 0.1 mg/kg bolus for muscle relaxation. Additional doses of
vecuronium were given as deemed necessary by the attending anesthesiologist.
Group K received an
intravenous bolus of ketamine 0.2 mg/kg before skin incision followed by 0.2
mg/kg/hour until the end of the procedureand group L received an intravenous bolus dose of preservative free
2% lignocaine 2 mg/kg before skin incision followed by 2 mg/kg/hour till the
end of the procedure. Intra-operatively, patient’s vital signs were recorded
periodically and patients having fluctuations in HR and MAP >30% of baseline
value were treated accordingly. After the completion of the procedure, all infusions
were stopped and the patient reversed with Neostigmine and Glycopyrrolate and extubated. The time for extubation and the time for
response to oral commands were recorded.
After the procedure, patients were monitored in the
recovery room and in the post-operative ward. Any perioperative complications
such as tachycardia, bradycardia, hypertension, hypotension, nausea, vomiting,
muscle twitching, seizures, respiratory depression were watched for.
Numerical Rating Scale for pain were assessed serially at 10
minutes, 30 minutes, 1 hour, 4 hours, 12 hours and 24 hours after surgery. Inj.
Paracetamol 1 gram iv and inj. Tramadol 50 mg iv were given as the first line
and second line rescue analgesics respectively and were administered if NRS ≥
4. The time for first analgesic request was recorded. The duration of analgesia
was taken as the time at which patient complained of pain or the NRS was ≥ 4
on assessment at serial intervals. The total dose of rescue analgesics needed
in the first 24 hours were also recorded. Postoperatively, sedation was assessed soon after
extubation and after 30 minutes by using modified
Ramsay sedation score. Development of chronic postsurgical pain was assessed by telephonic enquiry of all patients after 3 months of surgery. |