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Completed

NCT Number: NCT03958513

To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU
  • Patients who are eligible according to ASA Ⅰ -Ⅱ
  • Female or male, age ≥18 years
  • Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy
  • Discharge of patient between 12 hour to 36 hour after performing procedure
  • Patients given consent for enrollment in study

Exclusion criteria

  • Patients known to be allergic to certain recommended drugs
  • If patients have history of psychiatric illness
  • Patients on chronic analgesic therapy for any other indication
  • Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy
  • Duration of surgery more than 1 hour
  • Patients undergoing laparoscopic cholecystectomy for complex gallbladder disease such as incidental gallbladder pancreatitis, gallstone pancreatitis, cholecystoduodenal fistula, mirizzi syndrome
  • Special population group such as children, pregnant woman, patients with cirrhosis, diabetics
  • Duration of operative procedure more than 1 hour

Treatment and study plan

Bupivacaine

Drug

1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

0.9% normal saline

Drug

1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy

Primary outcomes

  1. Post-operative pain: VAS

    Time frame: 12 hours

    Post-operative pain in visual analog scale ranging 0 to100

  2. Post-operative pain: rating scale

    Time frame: 12 HOURS

    Post-operative pain in numerical rating scale ranging 0 to 4

Secondary outcomes

  1. Patient Satisfaction Level: questionnaire

    Time frame: 24 hour

    Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present.

  2. Hospital stay

    Time frame: 3-5 days

    Time frame for hospital discharge

  3. Pain during hospital discharge: VAS

    Time frame: 3-5days

    visual analog scale score during hospital discharge rangibg 0-100

  4. Time taken to return to job and normal activities

    Time frame: 15-30 days

  5. Assesment of quality of life: index

    Time frame: 15th and 30th post-operative day

    Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Randomized, Double- Blind, Controlled Trial to Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 22, 2019
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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