Compare the pain releif benefit of Ultrasound guided abdominal plane nerve block and standard pain releief technique in patients following cesarean delivery and its relation with OXTR gene

Phase 4

Completed

• Conditions: Encounter for full-term uncomplicated delivery,

• Registration Number: CTRI/2020/01/022813
• Lead Sponsor: University College Of Medical Sciences

Brief Summary

The present randomized controlled study aims to compare the ultrasound-guided Transversalis fascia plane block and standard multimodal analgesia technique utilizing wound infiltration for post-caesarean pain management and comparison of mRNA expression of OXTR gene between the two groups. Standard anaesthetic technique for subarachnoid block will be adopted in all patients undergoing caesarean section. Patients will be randomized into two groups. A total of 60 patients with 30 patients in each group will be recruited, in Group C, patients will receive standard multimodal analgesia including wound infiltration (20 ml of 0.375% ropivacaine) at the end of the surgery and patients in group-T, will receive bilateral Ultrasound-guided Transversalis fascia plane block (20 ml of 0.375% ropivacaine) at the end of the surgery. In both the groups, exogenous oxytocin administration after the baby delivery and post operative analgesia will be done as per the standard protocol. Patient’s pain assessment will be done at various designated intervals till 14th week. Blood sample will be withdrawn at baseline and at the end of 14th week for gene expression study. The primary objective is to determine and compare the time to first request of analgesia between the two groups  The Secondary Objectives are to determine and compare the NRS pain score at rest and movement at 1st, 6th, 12th, 24th hours and at the end of 6th, 10th and 14th week, total consumption of rescue analgesic in the first 24 hours, Pain detect questionnaire (PDQ) score and Neuropathic pain symptom inventory (NPSI) score and the quality of life using short form (SF)-12 questionnaire at the end of 6th, 10th and 14th week and incidence of chronic persistent post-surgical pain (CPSP) at the end of 14th week. Comparison of mRNA expression of OXTR genes will be done between the two groups at baseline and then at the end of 14th week.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Study Completion: 2021-07-31
• Last Update Posted: 2024-01-21

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Patients of ASA grade I or II undergoing lower segment caesarean section with pfannenstiel incision under subarachnoid block.

Exclusion Criteria

Patients having other causes of chronic pain,Patients having cognitive dysfunction or inability to comprehend various questionnaires, Patients having chronic neurological disorders/substance abuse,body mass index (BMI) > 40 kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine and compare the time to first request of analgesia between the two groups	The Time to first request of analgesia will be measured from completion of the intervention i.e. wound infiltration or abdominal plane block following the completion of surgery till the patients first demand for analgesia

Secondary Outcome Measures

Name	Time	Method
NRS pain score at rest and movement,	Total consumption of diclofenac in 24 hours, Pain detect questionnaire (PDQ), NPSI scores, SF-12 score,

Trial Locations

Locations (1)

University College Of Medical Sciences and GTB Hospital; 🇮🇳 East, DELHI, India

University College Of Medical Sciences and GTB Hospital

🇮🇳East, DELHI, India

Diksha Gaur

Principal investigator

09818392246

diksha.gaur@gmail.com