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CTRI Number  CTRI/2025/03/082969 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Quality of recovery after Hip replacement surgery  
Scientific Title of Study   Quality of Recovery after Total Hip Replacement: A Randomised Double-Blinded Study Comparing Intrathecal Morphine and Ultrasound Guided Sacral Erector Spinae Block 
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 Ananya Mishra 
Designation  PG Resident 
Affiliation  AIIMS, Bhubaneswar 
Address  C/O- Dr Alok Kumar Sahoo Dept of Anesthesiology & Critical Care Fifth Floor Room No-8 Hospital Building. AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7987349801  
Fax    
Email  mishraananya94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alok Kumar Sahoo 
Designation  Additional Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room No 8. 5th Floor Hospital Building

Khordha
ORISSA
751019
India 
Phone  9438884160  
Fax    
Email  alokks108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alok Kumar Sahoo 
Designation  Additional Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no8, 5th floor Hospital Building. AIIMS, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884160  
Fax    
Email  alokks108@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar, Dist-Khordha Odisha, 751019 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS, Sijua. Bhubaneswar, Khordha, Odisha, 751019 
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 Ananya Mishra  AIIMS  Room No 8, Hospital Building, AIIMS, Bhubaneswar
Khordha
ORISSA 
7987349801

mishraananya94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, AIIMS, Bhubaneswar, Level 3 Academic Block  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M160||Bilateral primary osteoarthritis of hip, (2) ICD-10 Condition: M16||Osteoarthritis of hip, (3) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intrathecal Morphine(ITM Groups)  100 mcg of Morphine will be mixed with 0.5% hyperbaric Bupivacaine 15 mg and a sham block will be given postoperatively 
Intervention  Ultrasound guided Sacral erector spinae plane block(ESPB Group)  Postoperative USG guided sacral erector spinae plane block (ESPB) with30 mL of 0.25% of Bupivacaine in a patient operated under SA with bupivacaine 0.5% 15 mg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults aged 18-80 years, ASA grade I, III, scheduled for elective primary total hip replacement surgery


 
 
ExclusionCriteria 
Details  Patients with bleeding disorders
Injection site infection
Vertebral column anomaly
Neurological disorders
Refusal to consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of recovery using the QoR-15 score .  24 hours after the surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the post-operative pain measured with NRS (0-10) score  at 2, 4, 12, and 24 hours after surgery. 
To compare time (in min) to first rescue analgesia    
Opioid requirement during the postoperative period   24hr of surgery 
Incidence of PONV, Pruritus, Urinary retention   24 hr. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   28/03/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Hip fractures and avascular necrosis are the leading causes of hip joint replacement in India, and the incidence is multiplying. Pain following THR surgery is a significant concern, and it could be as high as 81%, as reported by previous studies, with the mean persistent post-surgical pain rate being around 16.5%. [1] Adequate analgesia with minimal side effects allows for early postoperative mobility, optimal functional recovery, and decreased postoperative morbidity [2]. Despite being a frequently performed surgical procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty [3, 4].

    There is strong evidence supporting the effectiveness of intrathecal morphine for pain relief after total hip arthroplasty, with no significant increase in the risk of respiratory depression with dose between 50 mcg to 100 mcg even in elderly and patients with risk of apnea.[5] The incidence of postoperative nausea and vomiting (PONV) after intrathecal morphine is dose dependent and dose less than equal to 100 µg  provide sufficient analgesia without increasing the risk of PONV. [5,6] PROSPECT guidelines for THR surgery recommend consideration of 100 mcg of intrathecal morphine administration if the procedure is being done in spinal anaesthesia. [4]

        The ESPB is a regional block that targets both the dorsal and ventral roots of the spinal nerve, offering analgesia for both somatic and visceral pain. This technique facilitates the extensive distribution of local anaesthetics in a craniocaudal direction, effectively blocking multiple dermatomes. [4] Recently, some case studies suggested that the sacral erector spinae plane block (ESPB) also called as sacral multifidus block, was found to be an effective technique for providing postoperative pain relief in patients undergoing femoral fracture surgery via a posterolateral approach. [4] But this technique has not been extensively studied for adult patients undergoing hip surgeries. There is paucity of literature comparing sacral ESPB and ITM which has quality of recovery (QoR15) as the primary outcome in THR surgery. Hence, we plan to compare effect of sacral ESP block with intrathecal morphine in the quality of recovery at 24hr after THR surgery.


 
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