| CTRI Number |
CTRI/2025/05/086261 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF THE EFFICACY OF OPIOID-FREE ANESTHESIA AND OPIOID-BASED ANESTHESIA IN FEMALE LAPAROSCOPIC STERILIZATION |
|
Scientific Title of Study
|
Comparison of the Efficacy of Opioid-Free Anaesthesia and Opioid-Based Anaesthesia in Gynecological Laparoscopic Sterilization Under ERAS Protocol : 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 |
DrIkshit Singh |
| Designation |
Junior Resident |
| Affiliation |
Dr.Radhakrishnan Government Medical College |
| Address |
Hello Motors, Bypass road, near NEW CSD Canteen, Hamirpur
House no. 1343, Sector 26, Panchkula, Haryana
Hamirpur
HIMACHAL PRADESH
177030
India |
| Phone |
9988382293 |
| Fax |
|
| Email |
ikshitsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjit Singh Kanwar |
| Designation |
Assosciate Professor |
| Affiliation |
Dr.Radhakrishnan Government Medical College |
| Address |
Room no. 11, Doctors Residence, Near Dr Radhakrishnan Government Medical College, Hamirpur
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
8219500838 |
| Fax |
|
| Email |
drmanjitkanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManjit Singh Kanwar |
| Designation |
Assosciate Professor |
| Affiliation |
Dr.Radhakrishnan Government Medical College |
| Address |
Room no. 11, Doctors Residence, Near Dr Radhakrishnan Government Medical College, Hamirpur
Hamirpur
HIMACHAL PRADESH
177001
India |
| Phone |
8219500838 |
| Fax |
|
| Email |
drmanjitkanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Radhakrishnan Government Medical College |
|
|
Primary Sponsor
|
| Name |
Ikshit Singh |
| Address |
Hello Motors, Bypass road, near NEW CSD Canteen, Hamirpur |
| Type of Sponsor |
Other [Self] |
|
|
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 Ikshit Singh |
Operation Theatre |
Room no 410, Dr Radhakrishnan Government Medical College
Hamirpur
HIMACHAL PRADESH |
9988382293
ikshitsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z302||Encounter for sterilization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid-Based Anesthesia |
Opioid-Based Anaesthesia (OA) Group receives premedication with Midazolam 0.05mg/kg (I.V). This will be followed by dexamethasone 8mg IV and Fentanyl(opioid) at a dose of 2 µg/kg IV. Normal saline 2-3ml IV will be given in opioid group to ensure blinding. Patient will be induced with propofol at 2 mg/kg, and atracurium at 0.5 mg/kg followed by I gel insertion. The maintenance of anaesthesia will be achieved with Oxygen and Nitrous oxide (30:70) along with Propofol infusion and PCM for analgesia, mirroring the Opiod-free groups maintenance strategy but differing in the initial induction phase due to the inclusion of opioids. An increase in mean blood pressure or heart rate by more than 30% of baseline value despite adequate anaesthetic depth during surgery will be considered a nociceptive response and treated by administering a bolus of IV fentanyl (1 µg/kg). The total dose of IV fentanyl given in the intra-operative period will be documented. Paracetamol (PCM) at 15 mg/kg IV and ondansetron 0.15 mg/kg IV will be given prior to completion of surgery and local infiltration of incision site will be done with 5 ml of 0.25% bupivacaine. The approach to postoperative analgesia in the OA group remains consistent with the OFA group, utilizing Diclofenac IV at 1.5 mg/kg to manage pain after the surgery when Visual Analogue score above 4. |
| Intervention |
Opioid-Free Anesthesia |
For the Opioid-Free Anaesthesia (OFA) Group, Midazolam at 0.05mg/kg iv will be given 1 min prior to induction along with IV doses of dexamethasone 8mg, Ketorolac at a dose of 0.5 mg/kg, Ketamine at 0.5 mg/kg. Induction will be done with IV Propofol at 2 mg/kg, and Atracurium at 0.5 mg/kg followed by insertion of an I-Gel for securing airway for mechanical ventilation. The maintenance of anaesthesia will be done with a mixture of Oxygenand Nitrous oxide (30:70), supplemented with a continuous infusion of Propofol(100 micrograms/kg/min). IV Paracetamol(PCM) at 15 mg/kg and Ondansetron 0.15 mg/kg will be given prior to completion of surgery. Local infiltration of 5 ml of 0.25% bupivacaine will be given at incision site. Neostigmine (0.05 mg/kg) and glycopyrrolate (0.02 mg/kg) will be administered for reversal of any residual neuromuscular block, followed by removal of Igel in fully awake state.Postoperatively, rescue analgesic Diclofenac IV(1.5 mg/kg) will be given when Visual Analogue score above 4, aimed at ensuring effective pain relief in the recovery phase. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Scheduled for elective gynecological laparoscopic sterilisation.
2.Able to provide informed consent.
3.ASA grade I or II.
4.Hemodynamically stable with no acute medical illness requiring urgent intervention.
5.Not pregnant or breastfeeding.
6.No known allergies to study medications.
7.Willing to comply with study procedures and follow-up assessments. |
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries or surgeries requiring conversion to open procedures.
2.ASA physical status above II.
3.History of significant cardiac, hepatic, renal, or respiratory disease.
4.Known allergy or contraindication to study medications.
5.Chronic opioid use or dependence.
6.Pregnancy or breastfeeding
7.Inability to provide informed consent.
8.Any condition deemed by the investigator to pose a risk to the patient or interfere with the study procedures.
9.Duration of surgery more than 30 min. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative Pain Control and Recovery Outcomes |
Preoperative (baseline assessment)
Intraoperative (during surgery)
Postoperative:
a. Immediate postoperative period (e.g., recovery room)
b. 24 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative pain scores and analgesic requirements in first 24 hours post-surgery
2. Intraoperative hemodynamic stability during surgery
3. Patient satisfaction with the anesthetic technique post-surgery
4. Quality of recovery (QoR) using the QoR-15 questionnaire Post-surgery |
Postoperative pain scores and analgesic requirements: within 24 hours post-surgery
Intraoperative hemodynamic stability: During surgery
Patient satisfaction with the anesthetic technique: Post-surgery
Quality of recovery (QoR) using the QoR-15 questionnaire: Post 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 |
|
Date of First Enrollment (India)
|
13/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/05/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to compare the efficacy of opioid-free anesthesia (OFA) versus opioid-based anesthesia (OA) in gynecological laparoscopic sterilization surgeries within the framework of Enhanced Recovery After Surgery (ERAS) protocols. With India’s high demand for efficient and safe surgical options, particularly in family planning methods, exploring optimized perioperative strategies is imperative. Gynecological laparoscopic surgeries have gained popularity due to their minimally invasive nature and associated benefits such as reduced postoperative pain and shorter hospital stays. The adoption of ERAS protocols further enhances recovery outcomes by emphasizing multidisciplinary approaches to patient care. OFA represents a promising alternative to traditional opioid-based anesthesia, offering improved safety profiles and effective analgesia. However, its efficacy within ERAS protocols, particularly in gynecological laparoscopic surgery, requires further investigation. Several studies have examined OFA’s impact on perioperative outcomes, indicating comparable efficacy to OA in terms of pain control and recovery parameters. However, concerns regarding prolonged recovery times and sedation levels necessitate additional research. The proposed study will be a prospective, randomized, double-blinded controlled trial conducted at Dr. Radhakrishnan Medical College, focusing on postoperative pain control, recovery outcomes, and patient satisfaction. The primary objective is to determine if OFA is non-inferior to OA in terms of pain control, satisfaction, and recovery time. Secondary objectives include assessing postoperative pain scores, hemodynamic stability, patient satisfaction, and quality of recovery using the QoR-15 questionnaire. The study will enroll 62 female participants aged 25 to 45 years scheduled for elective gynecological laparoscopic sterilization surgeries. Anesthesia techniques, data collection, and statistical analysis will adhere to established protocols. Ethical considerations and patient safety will be paramount throughout the study. By evaluating the comparative efficacy of OFA and OA within ERAS protocols, the study aims to refine anesthesia approaches and improve patient outcomes in gynecological laparoscopic surgeries. |