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CTRI Number  CTRI/2022/04/041624 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexamethasone, Paracetamol and Ketorolac combination for pain relief and opioid sparing effects in total laparoscopic hysterectomy  
Scientific Title of Study   To compare the opioid sparing effects Of combination Of dexamethasone , paracetamol and ketorolac(DexPak) VS paracetamol , ketorolac in patients undergoing total laparoscopic hysterectomy: a prospective double blind randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parin Lalwani 
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology , Pain Medicine and Critical Care, Room no 1 Porta cabin Fourth Floor Teaching Block,AIIMS New Delhi. South Delhi

New Delhi
DELHI
110029
India 
Phone  9650533388  
Fax    
Email  drparinlalwani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Parin Lalwani 
Designation  Assistant Professor  
Affiliation  All India Institute of Medical sciences 
Address  Department of Anaesthesiology , Pain Medicine and Critical Care, Room no 1 Porta cabin Fourth Floor Teaching Block,AIIMS New Delhi. South Delhi

New Delhi
DELHI
110029
India 
Phone  9650533388  
Fax    
Email  drparinlalwani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Isha Nene 
Designation  Junior resident  
Affiliation  All India Institute of Medical sciences 
Address  Department of Anaesthesiology , Pain Medicine and Critical Care. AIIMS New Delhi. South Delhi

New Delhi
DELHI
110029
India 
Phone  9890464104  
Fax    
Email  inene714@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology , Pain Medicine and Critical care , AIIMS, new Delhi 
 
Primary Sponsor  
Name  Parin Lalwani 
Address  Department of Anaesthesiology , Pain Medicine and Critical Care. AIIMS New Delhi. South Delhi  
Type of Sponsor  Other [Self] 
 
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 
Parin Lalwani  All India Institute of Medical sciences  Department of Anaesthesiology , Pain Medicine and Critical Care, Room no 1 Porta cabin Fourth Floor Teaching Block,AIIMS New Delhi. South Delhi
South
DELHI 		 9650533388

drparinlalwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone 0.2mg/kg ,ketorolac 30mg, Paracetamol1g   Intravenous Dexamethasone will be given 1 hour before surgery. Intravenous Paracetamol and ketorolac will be given before induction of anaesthesia  
Comparator Agent  Placebo 10ml 0.9% normal saline, ketorolac 30mg ,Paracetamol 1g  Intravenous saline as placebo will be given 1 hour before surgery. Paracetamol and ketorolac will be given before induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients of ASA physical status I and II posted for elective total laparoscopic hysterectomy 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Known allergy to the drugs
3. History of chronic analgesic or steroid consumption
4. History of gastric or duodenal ulcer
5. BMI >30
6. History of asthma
7. History of diabetes mellitus
8. History of endometriosis
9. Chronic alcoholism
10. Liver and/or kidney dysfunction
11. Limitations in understanding use of PCA pump
12. Duration of surgery >2 hrs / converted to open surger
 
 
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 
Total intravenous Patient controlled analgesia(PCA) fentanyl consumption in the first 24 hours postoperatively  24 hours postoperatively  
 
Secondary Outcome  
Outcome  TimePoints 
1. Time for first analgesic requirement  24 hours postoperatively  
2. Post operative pain scores at rest and during movement 0min 15min 30min 1,2,4,8,12 and 24 hours postoperatively

 		 0min, 15min, 30min , 1,2,4,8,12,24 hours 
Post operative nausea and vomiting   0min, 15min, 30min , 1,2,4,8,12,24 hours 
Wound healing  7 days postoperatively  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2022 
Date of Study Completion (India) 04/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In recent times total laparoscopic hysterectomy has emerged as a new treatment modality which is quickly replacing the open abdominal hysterectomy. It has many advantages over abdominal hysterectomy of less postoperative morbidity, shorter hospital stay, being minimally invasive and faster recovery[1,2] . Despite these advantages, TLH is often associated with unexpectedly high levels of pain, most commonly due to inadequate pain control . Pain after TLH can be due various manipulation like pneumoperitonium, stretching of intra abdominal cavity and dissection of pelvic organs, apart from the incisional pain[3]

Opioids are one of the most common drugs used to alleviate postoperative pain, but they are associated with an array of side effects like sedation, reduced cognition, delirium, respiratory depression , nausea, vomiting ,ileus and pruritus[4]. These side effects cause delay in discharge and increase total cost of treatment.

In order to decrease these side effects multimodal analgesia using primarily non-opioid analgesics with additive or synergistic effects to produce superior analgesia while decreasing opioid use and side effects is being used. The most common non-opioid drugs used in multimodal analgesia regimen are acetaminophen, non-selective NSAIDS, selective COX-2(cyclooxygenase) NSAIDS, steroids , GABA agonists[gabapentin and pregabalin][5,6,7].

In our study we have used a combination of 3 drugs, Paracetamol, Ketorolac and Dexamethasone for a multimodal analgesia regime.

Paracetamol is a drug that is invariable used in multimodal analgesia regimens. Many clinical trial for gynaecological surgeries have shown that paracetamol provides better analgesia compared to a placebo and reduces opioid consumption[8,9,10]

 

 Ketorolac tromethamine is an NSAIDS which can be used intravenously. It has both analgesic and anti-inflammatory properties and can be used in moderate to severe post operative pain. It primarily act through inhabitation of prostaglandin synthesis via the Cox(cyclooxygenase) pathway. Studies have revealed that Ketorolac reduces postoperative pain and has opioid sparing effects but is less effective as a sole analgesic in moderate to severe postoperative pain[11,12]. Hence it is used in combination with other analgesic in multimodal analgesia regimes.

Dexamethasone is a glucocorticoids with a well established analgesic and anti-emetic properties.

 

Thus the hypothesis of our study is that addition of preemptive Dexamethasone  to paracetamol and ketorolac combination will decrease cumulative opioid consumption as compared to paracetamol and ketorolac in women undergoing elective total laparoscopic hysterectomy.

         

 

                                                     REFERENCES

1.Kluivers KB, JOHNSON NP , Chein P, Vierhout ME, Bongers M, Mol BW. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life:a systemic review . Eur J Obset gynecol reprod biol. 2008;136:3-8.

2.         Thiel J , Gameril A. Outpatient total laparoscopic hysterectomy . Journal of  American association of  gynecologic laparoscopists.2003;10:481-3.

3.         Choi JB , Kang K ,  Song MK , Seok S ,  Kim YH . Pain characteristics after laparoscopic hysterectomy. International journal of medical sciences.2016;13(8): 562.

4.Bowdle TA. Adverse effects of opioid agonist and antagonist in anaesthesia . Drug safety. 1998;19:173-89.

 

 

5. Lirk P ,  Thiry J ,  Bonnet M , Joshi G ,  Bonnet F . Pain management after laparoscopic hysterectomy ; systemic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019;44:425-436.       

 6.       Wardhan R ,  Chilly J . Recent advances in acute pain management:understanding the mechanisms of acute pain, the prescription of opioids, and role of multimodal pain therapy. 2017.

7 NelsonG , Altman AD , Nick A , Meyer LA ,  Ramirez PT . Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced recovery after surgery (ERAS) Society recommendations- part 2. Gynecologic oncology. 2016; 140: 323-332. 

8.Urman R ,  Boing E,  Pham AT. Improved outcomes associated with use of intravenous paracetamol for management of acute post surgical pain in cesarean section and hysterectomies . J clin med .2018;10[6]:499-507. 

9. Herring BO ,  Maldonado AS , Hawkins C, Kearson M ,Camejo M. Impact of intravenous acetaminophen on reducing opoid use after hysterectomy. Pharmacotherapy. 2014;34:27S -33S.    

10.Marchand G, Azadi A, Sainz K. Efficacy of acetaminophen in ERAS protocols for total  laparoscopic hysterectomy.2021.

11. Mather Le . Do pharmacodynamics of NSAIDS suggest a role in management of post operative pain? Drugs .1992;44:1-12.

12. Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine , ketorolac and their combination for post operative pain relief . Anaesthesiology. 2005;103:1225-32.

 

 

 

 

 

 
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