Bupivacaine Infiltration and Postoperative Pain

NCT04728308 | Unknown Early Phase 1

• 1 other identifier: A/28/EC/232/2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind randomized controlled trial to assess the efficacy of local infiltration of bupivacaine versus placebo, in reducing postoperative pain. The severity of pain will be assessed in terms of mean score on visual analogue scale, opioid requirement and average duration of hospital stay.

Conditions

Postoperative Pain; Local Infiltration; Analgesia

Keywords

Bupivacaine; Local anesthetic; cesarean section

Outcome Measures

Primary Outcomes (2)

• average pain score on Visual analogue scale

  average pain score on Visual analogue scale in first 12 hours after the surgery

  in first 12 hours after the surgery

• average opioid consumption

  average consumption of tramadol injection

  within first 24 hours after the surgery

Secondary Outcomes (1)

• average duration of hospital stay

  3 months

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

20ml of 0.5% bupivacaine is infiltrated in the subcutaneous tissue around the incision site

Drug: Bupivacain

Placebo group

PLACEBO COMPARATOR

20 ml of distill water is infiltrated in the subcutaneous tissue around the incision site

Drug: Bupivacain

Interventions

Bupivacain DRUG

Before closing the skin incision,Infiltration of 20ml of 0.5% bupivacaine around incision site will be done in the patients of experimental group and 20 ml of distill water will be infiltrated in the pateints of the placebo group

Experimental group; Placebo group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women with age between 20-40 years, American Society of Anesthesiologist (ASA) class II, BMI \< 35 at the time of surgery, a period of gestation 37+0- 40+0 weeks, elective caesarean section done under spinal anesthesia, skin incision pfennensteil and lower segment transverse incision on the uterus.

You may not qualify if:

• allergy to local anesthetic, emergency caesarean section, conversion of spinal anesthesia to general anesthesia, caesarean section due to abnormal placentation, midline skin incision, upper segment incision on uterus

Sponsors & Collaborators

• Armed Forces Hospital, Pakistan: lead

Study Sites (1)

Madiha Ahmed

Islamabad, 45710, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Madiha Ahmed

CONTACT

923345366225; madiha940@yahoo.com

Arshad Khushdil

CONTACT

drarshad104589@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Caesarean section will be done under spinal anesthesia by a well-trained consultant obstetrician. The surgeon will be provided with a 20 ml syringe filled either with 20 ml of 0.5% Bupivacaine or 20 ml of placebo (distill water). The syringe will be prepared by our researcher obstetrician. The contents of the syringe will be determined by numbers generated from the computer and the operating surgeon will be unaware of these contents. Before closing the skin incision, the operating surgeon will infiltrate the solution in subcutaneous tissue around the incision. Severity of pain , need for amount of opioids and duration of hospital stay will be assesed by doctor incharge in postoperative ward.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Arshad Khushdil

Model Details: Informed written consent will be taken. Patients will be divided into two groups randomly, by a computer-generated method. Caesarean section will be done under spinal anesthesia by a well-trained consultant obstetrician. The surgeon will be provided with a 20 ml syringe filled either with 20 ml of 0.5% Bupivacaine or 20 ml of placebo (distill water). The syringe will be prepared by our researcher obstetrician. The contents of the syringe will be determined by numbers generated from the computer and the operating surgeon will be unaware of these contents. Before closing the skin incision, the operating surgeon will infiltrate the solution in subcutaneous tissue around the incision.

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: January 10, 2021
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)