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Completed

NCT Number: NCT06605235

The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy

To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.

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Key information

Conditions

Cholecystectomy, Laparoscopic Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAF hospital

Islamabad, Capital Territory, 44000, Pakistan

About this study

Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective/emergency laparoscopic cholecystectomy
  • ASA grade I/II
  • Ages 18-75 years

Exclusion criteria

  • patients on chronic analgesics
  • pts receiving analgesics 24 hours prior to surgery
  • intraoperative bile spillage or drain placement
  • CBD exploration or T-tube insertion
  • BMI > 40 kg/m2
  • pts allergic to, or otherwise not able to receive medications being tested

Treatment and study plan

local anesthesia

Procedure

In Group A, patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure. Subjects in Group B received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites. In Group C patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites

Primary outcomes

  1. Visual analogue scale - pain score

    Time frame: 2-, 6-, 12-, 24-hours following surgery

    Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).

Secondary outcomes

  1. Shoulder tip pain

    Time frame: within 24 hours following surgery

    The time following surgery when shoulder tip pain was gone

  2. Flatus

    Time frame: within 24 hours following surgery

    Time to passing flatus

  3. nausea/vomiting

    Time frame: within 24 hours following surgery

    time when nausea/vomiting was not present in the patient

  4. Time to ambulation

    Time frame: within 24 hours following surgery

    time after surgery when the patient started ambulating

  5. rescue analgesia

    Time frame: within 24 hours following surgery

    number of times rescue analgesia was used

  6. Mean arterial pressure

    Time frame: 2-, 6-, 12-, 24-hours following surgery

    systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated

  7. Heart rate

    Time frame: 2-, 6-, 12-, 24 hours

    Heart rate was measured at intervals in beats per minute

  8. oxygen saturation

    Time frame: 2-, 6-, 12-, 24 hours

    oxygen saturation was noted at intervals

Sponsors and collaborators

Lead sponsor

Pakistan Air Force (PAF) Hospital Islamabad

Other

Registry information

Official study title

The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

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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