| CTRI Number |
CTRI/2024/04/065825 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of local application of local anesthetic drug with additives for pain relief after laparoscopic cholecystectomy surgery. |
|
Scientific Title of Study
|
Comparison of efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine vs Ropivacaine with Dexamethasone for pain relief after laparoscopic cholecystectomy; a prospective randomized, double blind study. |
| Trial Acronym |
Intraperitoneal infiltration |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Johnson P Abraham |
| Designation |
Junior resident |
| Affiliation |
St Johns medical College Hospital, Bangalore |
| Address |
Prayattumannil house
Eraviperoor p o
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta KERALA 689542 India |
| Phone |
9074707170 |
| Fax |
|
| Email |
johnsonpabraham001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa Bhimasen Joshi |
| Designation |
Assistant professor |
| Affiliation |
St Johns medical College Hospital, Bangalore |
| Address |
Flat no ebony 902
Salarpuria greenage apartments
Next to Oxford dental college
Bommanahalli Department of Anaesthesiology St Johns medical College Hospital, Koramangala Bangalore Bangalore KARNATAKA 5600068 India |
| Phone |
9901405136 |
| Fax |
|
| Email |
drshilpa.josh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Johnson P Abraham |
| Designation |
Junior resident |
| Affiliation |
St Johns medical College Hospital, Bangalore |
| Address |
Prayattumannil house
Eraviperoor p o
Thiruvalla
Pathanamthitta
Kerala
Pathanamthitta KERALA 689542 India |
| Phone |
9074707170 |
| Fax |
|
| Email |
johnsonpabraham001@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college hospital sarjapura road kormangala Bangalore 560034 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
St Johns medical college hospital sarjapura road kormangala Bangalore 560034 |
| Type of Sponsor |
Private 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 Johnson P Abraham |
St Johns medical college hospital |
Room no 3
2nd floor operation theatre
St Johns medical college hospital sarjapura road kormangala Bangalore 560034 Bangalore KARNATAKA |
9074707170
johnsonpabraham001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , St johns medical College 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 |
Ropivacaine with Dexamethasone |
After the completion of surgery, 40 ml of 0.2% Ropivacaine and 1 mcg/kg Dexmedetomidine will be instilled via trocar in the gallbladder fossa. Post-instillation hemodynamics such as systolic blood pressure, diastolic blood pressure, and heart rate will be recorded. Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation. The time to first rescue analgesia, the total amount of analgesics administered over 24 hours, and the frequency of any side effects (Postoperative nausea vomiting and Sedation score) will be recorded. |
| Comparator Agent |
Ropivacaine with Dexmedetomidine |
After the completion of surgery, 40 ml of 0.2% Ropivacaine and 1 mcg/kg Dexmedetomidine will be instilled via trocar in the gallbladder fossa. Post-instillation hemodynamics such as systolic blood pressure, diastolic blood pressure, and heart rate will be recorded.
Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation.
The time to first rescue analgesia, the total amount of analgesics administered over 24 hours, and the frequency of any side effects (Postoperative nausea vomiting and Sedation score) will be recorded.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients
Age: 18 - 59 years
Patients undergoing elective laparoscopic cholecystectomy surgery
Patients who are able to interpret Numerical rating scale scoring
|
|
| ExclusionCriteria |
| Details |
Presence of acute cholecystitis, and choledocholithiasis.
Patients on steroids
Pregnant and lactating women
Patients who have undergone previous abdominal surgery.
Laparoscopy getting converted to open surgeries
History of allergies to medications
Patient on beta blockers
Duration of surgery: more than 3 hours |
|
|
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 |
| To access the postoperative analgesia using NRS score in patients undergoing laparoscopic cholecystectomy using intraperitoneal instillation of ropivacaine and dexmedetomidine vs ropivacaine and dexamethasone |
Using NRS, the post-operative pain intensity will be measured for each patient at rest and during movement at 20 mins, 30mins, 1 hour, 2, 4, 6, 12, and 24 hours from the time of extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the time required for the first rescue analgesia
And the total dose of rescue analgesia over 24 hours
|
NRS scoring will be recorded 1,2,4,6,12,24 hours post operaatively. |
| To assess incidence of Postoperative nausea and vomiting and Sedation score |
Patient will be assessed at 20, 30 mins, 1,2,4,6,12,24 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)
|
01/05/2024 |
| 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="2" 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
|
Laparoscopic cholecystectomy (LC) has rapidly become the procedure of choice for routine gallbladder removal and is currently the most commonly performed major abdominal procedure. The patient complains more of visceral pain after laparoscopic cholecystectomy in contrast to the parietal pain experienced in open cholecystectomy. Dissection around the gallbladder bed and capno-peritoneum raises the intraperitoneal pressure, which results in peritoneal inflammation. This leads to visceral abdominal pain that gets aggravated by coughing, deep breathing, and movement. Various multimodal approaches have been tried to ameliorate post-operative pain, which includes parenteral opioids, NSAIDs, analgesic patches, steroids, and local infiltration of local anaesthetics alone or with additives. Intraperitoneal instillation of local anaesthetics (LA) block the visceral afferent signals and modify visceral nociception. However, as LAs are short-acting, adding adjuvants will prolong the duration of anaesthesia and enhance the analgesic effect.
All parenteral medications have associated adverse effects like respiratory depression, drug dependence or abuse, nausea, vomiting, CNS side effects, etc. Local anesthetics have the added advantage that they cause fewer systemic side effects. Adding adjuvants increases the duration of the postoperative analgesic effect. Dexamethasone is a strong, long-acting glucocorticoid that is effective in relieving postoperative pain as well as postoperative nausea in laparoscopic surgeries. Dexmedetomidine is an alpha-2 adrenergic agonist. Studies have shown that topical application of dexmedetomidine during nerve block can enhance the analgesic effect, reduce the dosage of local anaesthetic and improve the postoperative analgesic effect. There are very few studies comparing the efficacy of dexamethasone vs dexmedetomidine as adjuvants in intraperitoneal installation, and hence the following study is being undertaken. |