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CTRI Number  CTRI/2024/11/076927 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Spinal versus General Anaesthesia for Laparoscopic surgeries 
Scientific Title of Study   Comparison of the Effectiveness of Regional versus General Anaesthesia for Laparoscopic Gynecological and Surgical Procedures 
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 Shirley Stephen 
Designation  Assistant Professor 
Affiliation  Rajiv Gandhi institute of Medical Sciences Adilabad Telangana  
Address  Department of Anesthesiology Operation theatre complex Second floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana 504001

Adilabad
TELANGANA
504001
India 
Phone  9371231434  
Fax    
Email  shirley81@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shirley Stephen 
Designation  Assistant Professor 
Affiliation  Rajiv Gandhi institute of Medical Sciences Adilabad Telangana  
Address  Department of Anesthesiology Operation theatre complex Second floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana 504001

Adilabad
TELANGANA
504001
India 
Phone  9371231434  
Fax    
Email  shirley81@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shirley Stephen 
Designation  Assistant Professor 
Affiliation  Rajiv Gandhi institute of Medical Sciences Adilabad Telangana  
Address  Department of Anesthesiology Operation theatre complex Second floor Rajiv Gandhi institute of Medical Sciences Adilabad Telangana 504001

Adilabad
TELANGANA
504001
India 
Phone  9371231434  
Fax    
Email  shirley81@rediffmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi institute of Medical Sciences Adilabad Telangana 504001 
 
Primary Sponsor  
Name  Rajiv Gandhi institute of Medical Sciences Adilabad Telangana 
Address  Rajiv Gandhi institute of Medical Sciences Rickshaw colony Adilabad Telangana 504001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shirley Stephen  Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana  Department of Anaesthesiology, Operation theatre complex Second floor Rajiv Gandhi Institute of Medical Sciences Adilabad Telangana
Adilabad
TELANGANA 		 9371231434

shirley81@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Rajiv Gandhi institute of Medical Sciences Adilabad Telangana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  general anesthesia  Propofol Vecuronium opioids 
Intervention  Spinal anesthesia  bupivacaine 0.5% heavy with Buprenorphine Clonidine  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients of ASA grade I and II, undergoing laparoscopic surgical and gynaecological surgeries 
 
ExclusionCriteria 
Details  Patients with the following conditions will be excluded cardiac diseases IHD CAD
respiratory diseases COPD ILD Asthma
neuropsychiatric disorders
Obese patients Obstructive sleep apnea
Difficult airway and intubation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Better pain scores stable hemodynamic parameters comfort level and sedation scores with regional anaesthesia  regular intervals intra operatively and post operatively
 
 
Secondary Outcome  
Outcome  TimePoints 
duration of analgesia early mobilization early discharge from hospital  end operative 6hr 12hr 24hr postop  
 
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   Phase 4 
Date of First Enrollment (India)   30/11/2024 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  

AIM and OBJECTIVES

The aim of this study is to evaluate the efficacy of regional anesthesia in patients undergoing laparoscopic gynecological surgical procedures in terms of patient comfort, haemodynamic parameters, sedation scores, duration of analgesia and surgeon comfort levels.

REVIEW OF LITERATURE

General anesthesia (GA) is the most common and used technique for laparoscopic surgeries, because it controls surgical pain and improves patient comfort [1]; however, it is responsible for different adverse effects in the postoperative period including the need for rescue analgesics and antiemetics [2, 3]. The surgery, performed under regional anesthesia (RA), allows patient being admitted and discharged on the same day or within 24 h, lowering the risk of nosocomial infection, providing cost-effectiveness and earlier mobilization [4, 5].

It is responsible for less surgical stress response, postoperative pain, lower incidence of postoperative nausea and vomiting, and rapid bowel canalization [10]. Till before the Covid pandemic, only few cases on total laparoscopic hysterectomy are described in the literature [1]. But during the pandemic the need to minimise the spread of Covid infection and to follow safety protocols led anesthesiologists to explore the various methods of regional anesthesia. 

MATERIALS AND METHODOLOGY

This is a Prospective Randomised single-blinded controlled study to be conducted at a tertiary care hospital RAJIV GANDHI INSTITUTE OF MEDICAL SCIENCES, ADILABAD, TELANGANA, India.

The patients will be randomly allocated to receive either General or regional anesthesia for the surgery. Baseline hemodynamic parameters will be monitored and appropriate anesthesia administered as per the protocol. If any discomfort for the patient or operating field discomfort to the surgeon, appropriate measures will be taken like sedation, pain relief medications or conversion to general anesthesia.

The following data will be analysed to determine the efficacy of the mode of anesthesia

- Mode of anesthesia administered: General, Regional or combination

- Pain scores,comfort levels and sedation scores at various intervals

- Hemodynamic parameters during the surgery

- Comfort score of the operating surgeon based on field visibility, additional ports access

- Time of mobilization in the post operative period and day of discharge

STATISTICAL ANALYSIS

    1. Statistical analysis will done using the SPSS software.

    2. Student`s t-test will be used for analyzing age, weight, MAP, HR, RR, duration of surgery and onset times

    3. Repeated measures analysis of variance is used to compare continuous variables. The difference in continuous parameters such as patient characteristics, preoperative data and amount of supplemental analgesic will be analyzed using one-way analysis of variance.

    4. Chi-Square test is used to analyze ASA class and modes of anesthesia, drug requirements between the two groups.

    5. Kruskal Wallis test will be used for non-parametric quantitative data like VAS score for post operative pain intensity and Ramsey’s sedation scores.

    6. A p-value of less than 0.05 is considered statistically significant

REFERENCES

1. Munro A, Sjaus A, George RB (2018) Anesthesia and analgesia for gynecological surgery. Curr Opin Anaesthesiol 31(3):274–279.

2. Stones J, Yates D (2019) Clinical risk assessment tools in anaesthesia. BJA Educ 19(2):47–53.

3. Harris M, Chung F (2013) Complications of general anesthesia. Clin Plast Surg 40(4):503–513

4. Darwin L (2016) Patient selection for day surgery. Anaesthesia & Intensive Care Medicine 17(3):151–154

5. Ljungqvist O, Scott M, Fearon KC (2017) Enhanced recovery after surgery: a review. JAMA Surg 152(3):292–298

6. Luigi Della ,Corte Antonio Mercorio, Mario Palumbo, Francesco Viciglione, Valeria Cafasso Minimally invasive anesthesia for laparoscopic hysterectomy: a case series, Archives of Gynecology and Obstetrics (2022) 306:2001–2007

7. Major, A.L.; Jumaniyazov, K.; Yusupova, S.; Jabbarov, R.; Saidmamatov, O.; Mayboroda-Major, I. Laparoscopy in Gynecologic and Abdominal Surgery in Regional (Spinal, Peridural) Anesthesia, the Utility of the Technique during COVID-19 Pandemic. Medicines 2021, 8, 60

8. Col R.K. Singh, Lt Col A.M. Saini, Lt Col Nitin Goel, Col Dinesh Bisht, Col Atul Seth, Major laparoscopic surgery under regional anesthesia: A prospective feasibility study, Medical journal armed forces India 71(2015)126-131


 
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