comparison of drugs for post operative pain relief in caesarean section

Not yet recruiting

Conditions: Encounter for other specified postprocedural aftercare, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2023/03/050565

Lead Sponsor: Maharaja Agrasen Medical College, Agroha

Brief Summary: Caesarean section is one of the most frequently performed surgeries in obstetrics. Optimal pain relief of the mother results in early mobilization and initiation of breast feeding. Multimodal analgesia is expected to provide high quality analgesia. Different methods such as drugs [nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, corticosteroids], and peroperative local anaesthetic infiltration have been used to reduce pain. Subcutaneous administration of opiates is a method of postoperative pain control after caesarean section. In our study, we aim to compare the analgesic efficacy of wound infiltration with tramadol versus bupivacaine for postoperative pain relief in caesarean section under subarachnoid block. A total of 80 patients will be randomly allocated into 2 groups with 40 patients in each group. Patients belonging to group T will receive tramadol hydrochloride 2 mg/kg in 20 mL of 0.9% normal saline while those belonging to group B will receive 20 mL of 0.25% isobaric bupivacaine. In the postanesthesia care unit (PACU) and ward, pain will be assessed using a Numerical Rating Scale. Incidence of side-effects such as nausea, vomiting, and shivering will be noted. The consumption of ondansetron and the rescue analgesics (Diclofenac and Paracetamol) over the first 24 h following surgery will be noted. Thereafter, comparisons will be made among the two groups based on the data collected. The different variables and occurrence of side effects, if any, would also be noted and compared amongst all groups. Since this is a randomized prospective trial, the anticipated outcome cannot be commented upon.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

American Society of Anaesthesiologistsâ€™ physical status II.
Patients undergoing caesarean section under subarachnoid block.

Exclusion Criteria

Patients 1.
who refuse to give consent 2.
with severe cardiopulmonary, renal or liver disease, pre-eclampsia, eclampsia, seizure disorder.
with contraindication to spinal anaesthesia like local site infections, coagulopathies or any spinal deformities.
who have infection at surgical site.
with history of allergy or hypersensitivity to local anaesthetics 6.
with psychiatric illness that would interfere with assessment of pain will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between the analgesic efficacy of wound infiltration with tramadol and bupivacaine for postoperative pain using NRS and time of rescue analgesia.	Assessment of post operative pain and time of rescue analgesia for upto 24 hours.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events.	24 hours post operative.

Trial Locations

Locations (1): Maharaja Agrasen Medical College
🇮🇳
Hisar, HARYANA, India
Maharaja Agrasen Medical College
🇮🇳Hisar, HARYANA, India
Ruchika Kathuria
Principal investigator
8053440544
ruchikakathuria15@gmail.com