| CTRI Number |
CTRI/2024/10/075023 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Painkiller injection given locally for post-operative pain management after knee ligament surgery |
|
Scientific Title of Study
|
Analgesic efficacy of wound infiltration with fentanyl or bupivacaine or bupivacaine with fentanyl in arthroscopic anterior cruciate ligament reconstructive surgery: A double blind randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhuwan Chand Panday |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar
Central DELHI 110060 India |
| Phone |
9999200881 |
| Fax |
|
| Email |
bhuwancp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shamly Jindal |
| Designation |
DNB Trainee |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar
Central DELHI 110060 India |
| Phone |
8222888868 |
| Fax |
|
| Email |
Simplyfab19.1994@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhuwan Chand Panday |
| Designation |
Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar
DELHI 110060 India |
| Phone |
9999200881 |
| Fax |
|
| Email |
bhuwancp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital,New Delhi |
| Address |
Rajinder nagar,New delhi,110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhuwan Chand Panday |
Ot complex |
6th and 7th floor SSRB BUILDING
Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi Central DELHI |
9999200881
bhuwancp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group B- Bupivacaine 0.25%
|
Group B: Surgical site will be infiltrated with 10 ml of 0.25% bupivacaine hydrochloride. |
| Intervention |
Group BF - Bupivacaine Fentanyl |
Group BF - Bupivacaine 0.25%+ Fentanyl 50 microgram in 10ml saline |
| Intervention |
Group F- fentanyl |
Group F- fentanyl 50 microgram in 10ml saline
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Physical Status: ASA grade I and II |
|
| ExclusionCriteria |
| Details |
Patients not giving consent
- Patient with neuropathy
- ASA III and more
-History of hypersensitivity to the drugs under study
-History of substance abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain evaluation during first 24 hours as assessed by VAS |
At 2,4,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of requirement of first rescue analgesia, Supplemental analgesic requirement & side effects like sedation, nausea, & vomiting |
from time 0 to the onset of pain in 24 hours |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
20/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing anterior cruciate ligament reconstructivesurgery commonly complain of high-intensity pain in the postoperative period due to tear of muscles and ligaments etc. Postoperative pain is the leading cause of prolonged hospital stay and delayed rehabilitation. Conventionally, postoperative pain relief in anterior cruciate ligament reconstructive surgery is achieved by using systemic analgesics, preferably opioids, which have their own set of deleterious effects like nausea, vomiting, pruritus, respiratory depression, and sedation etc. Epidural morphine has also been shown to be effective for pain relief but it needs technical expertise and its use is associated with side effects like sedation and respiratory depression. Local infiltrative analgesia is advantageous in terms of fewer side effects and ease of application, but its analgesic effect is short-lasting. Many local anaesthetic agentslike bupivacaine are being used as local infiltrative analgesiabut has limited duration of action (4-6 hours). The peripheral analgesic effect of fentanyl was reported long back and recent scientific evidence has finally unravelled the presence of activated opioid receptors at the incision site. Initial few studies have shown a promising analgesic effect and therefore, it has rekindled interest in local infiltration of fentanyl for its potent peripheral analgesic effect. Interestingly, the localinfiltration of fentanyl is devoid of the distressing side effects of systemic opioids as mentioned above. We aim to conduct a double blind randomized controlled trial comprising of three groups with 35 patients in each group. Group ‘B’ will be infiltrated with 10 ml of 0.25% bupivacainehydrochloride. Group ‘F’ will be infiltrated with 50 micrograms of Fentanyl citrate diluted in 10 ml of normal saline and Group ‘BF’ will be infiltrated with 10 ml of solution containing 9ml of 0.25% bupivacaine hydrochlorideand 50 micrograms (1 ml) of fentanyl citrate at the surgical wound site in patients undergoing anterior cruciate ligamentreconstructive surgery under general anaesthesia. Post-surgery, we plan to assess pain relief with the help of visual analogue scale (VAS) and the total analgesic requirement of supplemental analgesic drugs will be recorded for 24 hours from infiltration of drug. Side effects of opioids namelynausea, vomiting and sedation will be assessed in all the threegroups. We anticipate that analgesic efficacy of fentanyl will be better than bupivacaine for wound infiltration in patients undergoing anterior cruciate ligament reconstructive surgeryunder general anaesthesia. |