Bupivacaine Infiltration and Postoperative Pain

January 29, 2021 updated by: arshad khushdil, Armed Forces Hospital, Pakistan

Does Bupivacaine Infiltration Reduce Postoperative Pain in Patients With Cesarean Section?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To compare the effect of bupivacaine wound infiltration with placebo during caesarean section in terms of mean pain scores, analgesic requirement, and duration of hospital stay

Introduction:

Over the last several decades, the rate of caesarean has increased rapidly.According to the data collected from 150 countries, almost 18.6% of the total births occur by caesareansection, with rates ranging from 6% to 27% in different regions. In Egypt and Turkey, the rate of caesarean section is more than 50%. In Pakistan, caesarean section rate was found to be 15.8% in 2013, with a rate of 11.5% in rural areas and 25.6% in the urban population.

Caesarean section is the most commonly performed surgical procedure nowadays and is associated with moderate to severe pain after the surgery. Pain after caesarean section occurs due to inadvertent damage to parietal peritoneum and nerve supply of skin.According to a survey done in America in 2003, it was found that upto 70% of the patients will experience severe pain postoperatively. Severe pain after caesarean section specifically affects mother-baby bonding, lactation, and patient recovery. It also leads to a prolonged hospital stay, reduced mobility, and consequently increasing the risk of thromboembolic disease in the postoperative period. Severe pain aftercaesarean delivery has also been found to be associated with postnatal depression and pain persisting after 8 weeks of delivery.Incaesarean delivery, the provision of effective postoperative analgesia is of key importance to facilitate early ambulation and infant care. It is also very important that the type of analgesia providedis safe, effective,and has minimal side effects for the mother and her baby.

The most appropriate method of analgesia for postoperative pain after caesarean section remains uncertain.Different methods have been used for this purpose. Parenteral opioids are the most commonly used method but associated nausea, vomiting, sedation, and risk of respiratory depression in mother and baby limits its use. Continuous epidural analgesia or patient-controlled analgesia also provide effective analgesia and have fewer adverse effects butare expensive and require special equipment and expertise.Infiltration of local anesthetic into subcutaneous tissue around the incision site has also been thought to relieve pain after caesarean section. Local anesthetic drugslike lignocaine and bupivacaine inhibit nerve impulses from the site of injury thus providing an analgesic effect. However,in this regard, there is no consistent evidence.Some studies show high efficacy while others report no benefit.

This study is being conducted to assess the effectiveness of wound infiltration of 20ml of 0.5% bupivacaine after the caesarean section on postoperative pain scores and analgesic requirement. If found effective this regimen can be implemented locally as it is cheap and simple to use.

Method: This will be a a double-blind randomized controlled trial. It is being conducted at the Department of Gynecology and Obstetrics, Pak Emirates Military Hospital from 10th January 2020 and will be completed till 10th april 2021. Pregnant women at term, with ages between 20 to 40 years, who are planned to undergo elective caesarean section, will included in the study. Patients are divided into two groups by a computer-generated lottery method. In group A, 20 ml of sterile water is infiltrated in the subcutaneous tissue around the incision site while 20 ml of 0.5% bupivacaine injection is infiltrated in patients of group B. The primary outcome measure is to asses the difference in postoperative pain among the two groups in terms of average pain score measure with help of visual analogue scale (VAS) and total dose of analgesia required in the first twenty four hours after the surgery. Secondary outcome is the average duration of hospital stay in patients of the two groups All the data will be entered and analyzed with help of SPSS version 16. For quantitative variables like mean pain score, average dose of opioid required, and average duration of hospital stay, the investigators will calculate mean and standard deviation and for qualitative variables like indication of the caesarean section, frequency and percentage will be calculated. To compare the quantitative variables between the two groups, unpaired T-test and for comparison of qualitative variables, chi-square test will be used. A p-value of <0.05 will be considered significant.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental group
20ml of 0.5% bupivacaine is infiltrated in the subcutaneous tissue around the incision site
Drug: Bupivacain
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
Placebo Comparator: Placebo group
20 ml of distill water is infiltrated in the subcutaneous tissue around the incision site
Drug: Bupivacain
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average pain score on Visual analogue scale
Time Frame: in first 12 hours after the surgery
average pain score on Visual analogue scale in first 12 hours after the surgery
in first 12 hours after the surgery
average opioid consumption
Time Frame: within first 24 hours after the surgery
average consumption of tramadol injection
within first 24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average duration of hospital stay
Time Frame: 3 months
average duration of hospital stay after the surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Anticipated)

April 10, 2021

Study Completion (Anticipated)

April 10, 2021

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A/28/EC/232/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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