Menu
Recruiting NCT07409688

Pain Relief Following Laparoscopic Cholecystectomy While Comparing Intra Abdominal Versus Sub Cutaneous Local Anesthetic Administration

Phase IV Interventional Laparoscopic Cholecystectomy Surgery Analgeisa Local Anesthetic Infiltration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperitoneal local anesthetic administration, Sub cutaneous administration of local anesthetic.
Who it may be relevant to
Registry conditions: Laparoscopic Cholecystectomy Surgery, Analgeisa, Local Anesthetic Infiltration. Basic parameters: 15 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Evaluation of Analgesic Outcomes of Intra-peritoneal Versus Subcutaneous Infiltration of Bupivacaine for Laparoscopic Cholecystectomy Patients "

Overview

Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. This local anesthetic can be administered either within abdominal cavity or at sit of small incisions.

Detailed description

Laparoscopic cholecystectomy is a minimally invasive surgical procedure involving removal of the gallbladder through multiple small trocar incisions. Compared with open surgery, this approach is associated with reduced postoperative pain, shorter hospital stay, and faster recovery. Despite its minimally invasive nature, postoperative pain remains a significant concern, particularly at port sites and from intraperitoneal irritation. Local anesthetic techniques have been shown to contribute to multimodal analgesia in laparoscopic surgery. Local anesthetic agents may be administered either intraperitoneally or by infiltration at trocar insertion sites to reduce postoperative pain and opioid requirements. However, the optimal route of local anesthetic administration for effective postoperative analgesia following laparoscopic cholecystectomy remains uncertain, warranting further clinical evaluation.

Interventions

  • Drug Intraoperitoneal local anesthetic administration
    Intraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon.
  • Drug Sub cutaneous administration of local anesthetic
    port site infiltration of 20ml of 0.25% Bupivacaine will be done. 6ml for 10mm ports and 4ml for 5mm ports respectively.

Primary outcome measures

  • Post opestive pain score [Time frame: This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively]
  • Rescue analgesia demand [Time frame: This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4]

Eligibility criteria

Inclusion criteria

  • ASA I and II

Exclusion criteria

  • Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Rawalpindi Teaching Hospital, Rawalpindi — Rawalpindi

Publications

  • Bano N, Hayat N, Saleem S, Javaid F, Rehman A, Mudassir. Comparison of intraincisional and intraperitoneal infiltration of local anaesthetic in laparoscopic cholecystectomy to control early postoperative pain. Professional Med J 2021; 28(2):192-196. https://doi.org/10.29309/TPMJ/2021.28.02.6013

Identifiers

NCT: NCT07409688 · 4726/RTH/RWP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗