| CTRI Number |
CTRI/2025/07/090265 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes
Other (Specify) [improving posoperative outcome] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Recovery Quality with Pecs Block (Opioid-Sparing) vs Opioid-Based Anesthesia in Breast Cancer Surgery Patients – A Randomized Trial |
|
Scientific Title of Study
|
Comparison of Quality of Recovery in opioid sparing with Pectoral nerve (Pecs) block vs opioid based anesthesia in patients undergoing Modified radical mastectomy surgery. A randomized controlled 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 |
Amit Gupta |
| Designation |
junior resident doctor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesiology , OT complex 5th floor , ipd building AIIMS Patna , Phulwari Sharif, Patna , Bihar
Patna
BIHAR
801507
India |
| Phone |
9354071067 |
| Fax |
|
| Email |
dramitofficial18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology , OT complex 5th floor , ipd building AIIMS Patna , Phulwari Sharif, Patna , Bihar
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of anaesthesiology , OT complex 5th floor , ipd building AIIMS Patna , Phulwari Sharif, Patna , Bihar
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , All India Institute of Medical Sciences Patna , Phulwari Sharif , Patna , Bihar , India, 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of anaesthesiology , OT complex , 5th Floor , IPD building, AIIMS Patna, Phulwari Sharif , Patna, Bihar , 801507, India. |
| 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 Amit Gupta |
All India Institute of Medical Sciences Patna |
Department of anaesthesiology OT-16 ,OT complex ,6th floor , IPD building ,Aiims Patna , Phulwari Sharif, Patna
Patna
BIHAR |
9354071067
dramitofficial18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee AIIMS PATN |
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 |
| Comparator Agent |
opiod based anaesthesoa |
Intraoperative:
Before induction:
1) Inj. Paracetamol 15 mg/kg infusion
2) Inj. Dexamethasone 0.1 mg/kg IV.
3) Fentanyl 2 mcg/kg induction followed by maintenance. If 20% change in HR or MAP, then fentanyl 0.5 mcg/kg.
STANDARD ANAESTHESIA PROCEDURE.7
Induction of General Anesthesia:
Preoxygenation was performed.
Control Group: fentanil 2 µg/kg IV.
All patients received propofol 1–2 mg/kg IV for induction to facilitate laryngeal mask insertion or Endotracheal tube.
Maintenance of Anesthesia:
Sevoflurane inhalation to achieve a bispectral index (BIS) of 40–60.
Reversal of Neuromuscular Blockade and Postoperative Analgesia:
Injection Neostigmine 0.05mg/kg and injection Glycopyrrolate 0.01mg/kg
Postoperative Care:
Patients were transferred to the PACU after endotracheal tube removal
|
| Intervention |
opiod sparing anaesthesia |
1) Before induction: Inj. Paracetamol 15 mg/kg infusion and
2) Inj. Dexamethasone 0.1 mg/kg IV.
2) Dexmedetomidine 0.75 mcg/kg 15 minutes prior to induction.10
1) Inj. Lignocaine 1.5 mg/kg.9
After induction:
1) Pecs II Block.
Patient Positioning:
a. Place the patient in the supine position with the arm abducted for optimal access.
Ultrasound Imaging:
b. Use a high-frequency ultrasound probe under the clavicle at the midclavicular line.
c. Identify the axillary artery and vein beneath the pectoralis major and minor muscles.
d. Move the probe distally and laterally towards the axilla, visualizing the ribs from the 1st to the 3rd.
e. At the 3rd and 4th ribs, identify the pectoralis major, pectoralis minor, and serratus anterior muscles.
PECS I Block:11
f. Insert the needle medial to lateral in an oblique manner under ultrasound guidance.
g. Advance the needle to the plane between the pectoralis major and minor muscles at the 3rd and 4th ribs.
h. Inject 10 ml of local anesthetic, confirming its spread under ultrasound visualization.
PECS II Block:8
i. Advance the needle to the plane between the pectoralis minor and serratus anterior muscles.
j. Inject 20 ml of local anesthetic while ensuring proper spread under ultrasound guidance.8
2) Inj. Dexmedetomidine 0.5 mcg/kg/h IV, adjusted to 0.1 mcg/kg/h according to systolic blood pressure, stopped before suturing.12
GROUP B - Opioid Based Analgesia
Intraoperative:
Before induction:
1) Inj. Paracetamol 15 mg/kg infusion
2) Inj. Dexamethasone 0.1 mg/kg IV.
3) Fentanyl 2 mcg/kg induction followed by maintenance. If 20% change in HR or MAP, then fentanyl 0.5 mcg/kg.
Maintenance of Anesthesia:
Sevoflurane inhalation to achieve a bispectral index (BIS) of 40–60.
Reversal of Neuromuscular Blockade and Postoperative Analgesia:
Injection Neostigmine 0.05mg/kg and injection Glycopyrrolate 0.01mg/kg
Postoperative Care:
Patients were transferred to the PACU after laryngeal mask/ et tube removal.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
American society of anaesthesiologist (ASA) class I and class II
Age group 18 to 75
|
|
| ExclusionCriteria |
| Details |
Known metastasis with the exception axillary lymph nodes.
Refusal of the patient to participate in the study
History of chronic opioid use
Inability to understand the use of patient controlled analgesia (PCA) device
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery (QoR-40) at 24 hours postoperatively: Assessed using the QoR-40 questionnaire, focusing on patient recovery quality |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Opioid consumption: Total opioid consumption (measured in morphine milligram equivalents) within the first 24 hours postoperatively.
2. Pain scores: Measured using the Numeric Rating Scale (NRS) .
3. Time to oral intake: Time (in hours) from the completion of surgery to the initiation of a liquid diet.
4. Time to ambulation: Time (in hours) from the completion of surgery to when the patient can stand up and walk with assistance.
5. Postoperative nausea and vomiting (PONV): Incidence and severity of PONV within the first 24 hours postoperatively, assessed using a standardized scoring system.
6. Chronic pain at 3 months: Incidence and intensity of chronic pain, assessed using a patient-reported outcome tool (e.g., NRS or a chronic pain questionnaire).
|
24 hours and 3 months |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Opioids are commonly used in anesthesia to
manage pain during and after surgery. However, opioid-based anesthesia is
associated with potential side effects, including respiratory depression,
nausea, constipation, and the risk of dependency. With increasing concerns over
these adverse effects, there is growing interest in opioid-free anesthesia
approaches. In patients undergoing Modified Radical Mastectomy (MRM), effective
postoperative recovery is crucial, as these patients often experience
significant postoperative pain. This study aims to investigate whether
opioid-sparing anesthesia can provide comparable or superior postoperative
recovery outcomes to opioid-based anesthesia in MRM patients. |