Comparing the effectiveness of equal doses of Tramadol in wound infiltration versus transversus abdominis plane block after cesarian section under spinal anaesthesia in terms of post operative pain relief and early walking

Not yet recruiting

• Conditions: Complications predominantly related to the puerperium,

• Registration Number: CTRI/2023/10/058226
• Lead Sponsor: Dr. Uttara Saha

Brief Summary

This study aims to compare the efficacy of equal doses of Tramadol in wound infiltration versus Transversus Abdominis Plane block after LSCS under Spinal anaesthesia for post-operative analgesia.

The primary objective is to assess the duration of analgesia after wound infiltration versus Transversus Abdominis Plane block with Tramadol , in Lower Segment caesarean section patients.

The Secondary objective is (a) to know the total analgesic consumption in 24hours.

(b) to know the incidence of side effects like post operative nausea, vomiting and rashes at the site of injection of Tramadol.



Methodology - This prospective study will be conducted at our institution over a period of 1.5 years. In this study 140 American society of Anesthesiologists (ASA) physical status II female patients between age 18 to 45 years with BMI <35kg/m2 posted for lower segment caesarean section requiring spinal anesthesia will be included.

After taking written informed consent, patients will be randomized to two groups (n= 140) by block randomization. All patients will be thoroughly examined pre-operatively which include history, general physical examination, and checking the vital parameters of the patients such as blood pressure, pulse, respiratory rate and systemic examination, and ASA grading. The patients will be evaluated for any allergic reaction to Tramadol by performing skin test by injecting 0.1ml of Tramadol. The patients with a contraindication to spinal anesthesia or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities or allergic to Tramadol will be excluded.

While the patients are still on the operating table, patients will be randomized and will receive either wound infiltration (Group W) or TAP block (Group T).The total dose of Tramadol 2mg/kg will be diluted with 20ml NS. Wound infiltration will be given just before closure of the skin and in TAP block the diluted drug will be divided into 2 halves and will be given under USG guidance, between the lower costal margin and iliac crest on both sides, after closure of skin. Double blinding is done. The patient is blinded regarding the study drug and study procedure. The patient data collection and analysis will be done by anesthesiologists who are blinded regarding the study drug and study group.

Immediately after the operation, the patients will be shifted to the post op recovery room. Considering the baseline VAS score as zero, the VAS score will be serially assessed at regular intervals starting from 60 min to till 24hrs post surgery.

T0: Time of wound infiltration or TAP block

T1: 1hr after TAP block or Wound infiltration

T2: 2hrs after TAP block or Wound infiltration

T3: 3hrs after TAP block or Wound infiltration

T4: 4hrs after TAP block or Wound infiltration

T5: 5hrs after TAP block or Wound infiltration

T6: 6hrs after TAP block or Wound infiltration

T7: 7hrs after TAP block or Wound infiltration

T8: 8hrs after TAP block or Wound infiltration

T12: 12hrs after TAP block or Wound infiltration

T24: 24hrs after TAP block or Wound infiltration

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-29
• Study Start: 2023-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Patients posted for Lower segment caesarean section without any other comorbidities 2.
• Patient within the age group of 18 to 45 years 3.
• Patients under American society of Anesthesiologists (ASA) Physical status II 4.
• Patients with BMI <35 kg/m2.

Exclusion Criteria

• 1.Patient’s refusal 2.Patients under ASA III, ASA IV 3.Patient known allergic to local anesthetic agents and Tramadol 4.Patients with any coagulation disorders 5.Patients with severe cardiopulmonary, renal or liver disease, pre-eclampsia, eclampsia and morbidly obese.
• 6.Spine deformities or skin infection at local sites 7.Patients complaining of nausea and vomiting intraoperatively 8.Patient known for opioid dependency or other drug abuse 9.Duration of surgery more than 90mins.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the duration of analgesia after wound infiltration versus TAP block with Tramadol , in LSCS patients.	24 hours

Secondary Outcome Measures

Name	Time	Method
(a) to know the total analgesic consumption in 24hours.	(b) to know the incidence of side effects like post operative nausea, vomiting and rashes at the site of injection of tramadol

Trial Locations

Locations (1)

INSTITUTE OF MEDICALSCIENCES & SUM HOSPITAL; 🇮🇳 Khordha, ORISSA, India

INSTITUTE OF MEDICALSCIENCES & SUM HOSPITAL

🇮🇳Khordha, ORISSA, India

Dr Uttara Saha

Principal investigator

7005062562

uttarasaha88@gmail.com