Postoperative Pain
Conditions
Brief summary
Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder stones; however, the origin of pain after LC is multifactorial and complex in nature. Pain arising from incision sites is parietal pain, whereas pain from the gall bladder bed is mainly visceral in nature, and shoulder pain is mainly referred owing to the residual carbon dioxide irritating the diaphragm. Intraperitoneal administration of local anesthetics has been shown to improve postoperative pain control and reduce the need for systemic analgesics. The addition of adjuvant agents such as fentanyl or ketamine may further enhance analgesic efficacy. This randomized double-blind study aims to compare the effectiveness of intraperitoneal ketamine versus fentanyl as adjuvants to bupivacaine in reducing postoperative pain and analgesic requirements following laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy (LC) is widely recognized as the gold standard for the treatment of gallbladder stones due to its significant advantages over the conventional open surgical approach. These benefits include faster postoperative recovery, reduced surgical morbidity, shorter hospital stay, and decreased postoperative pain. Despite these advantages, postoperative pain remains a major concern and is considered one of the primary factors affecting patient comfort and delaying discharge following surgery. Abdominal pain is usually most pronounced during the first 24 hours after the procedure, while shoulder pain commonly develops on the second postoperative day as a consequence of diaphragmatic irritation caused by residual carbon dioxide. Because postoperative pain after laparoscopic surgery is multifactorial in origin, a multimodal analgesic approach is widely recommended . Various strategies have been employed to improve pain control, including the use of local anesthetics administered alone or in combination with intraperitoneal opioid analgesics. Intraperitoneal (I.P.) administration of local anesthetics has become a popular and effective technique for postoperative pain management, as it can reduce the need for systemic analgesics and minimize the adverse effects associated with nonsteroidal anti-inflammatory drugs and opioids. This approach was first investigated in gynecological laparoscopic procedures and has since been extensively studied in patients undergoing LC. Several studies have demonstrated that the addition of adjuvants such as fentanyl, a potent synthetic opioid, and ketamine, an N-methyl-D-aspartate receptor antagonist, may enhance and prolong postoperative analgesia. Consequently, intraperitoneal instillation of local anesthetics with adjuvant agents represents a simple, safe, and effective method for improving postoperative pain control following LC.
Interventions
DRUGFentanyl
Fentanyl used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 1 ug/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.
DRUGKetamine
Ketamine used as an adjuvant to bupivacaine for intraperitoneal instillation during laparoscopic cholecystectomy, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution. Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
An independent anesthesiologist randomly divided the patients into 42 groups of patients each using computer-generated random numbers fentanyl group and ketamine group (Group F and Group K). We discreetly placed the randomization results in envelopes until the end of the study. Both ketamine and fentanyl are colorless liquids, and they were digitally encoded so that the researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation.
Intervention model description
Instillation technique Intraperitoneal instillation of study drugs will be done by the operating surgeon through laparoscopic ports guided by surgical camera after the removal of the gall bladder, onto the gall bladder fossa, under the diaphragm, on the liver bed and patient position was changed to 15° 20° Trendelenburg position for 10 min. Intraperitoneal Instillation: The mixture of bupivacaine and fentanyl or Ketamine is instilled into the peritoneal cavity after securing hemostasis over the gall bladder bed. Study drug doses: Bupivacaine: Typically, 0.25% to 0.5% concentration is used for intraperitoneal instillation. A common volume is 20 mL, depending on the clinical protocol. Fentanyl group (42 patients): When used as an adjuvant to bupivacaine, a dose of 1 ug/kg is commonly added to the local anaesthetic solution. Ketamine group (42 patients): When used as an adjuvant to bupivacaine, a dose of 0.25 mg/kg is commonly added to the local anesthetic solution.
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of age 20-50 years * Patients of either gender * Patients planned to undergo elective LC. * Patients have I-II of the American Society of Anaesthesiologists (ASA)
Exclusion criteria
* Patient's refusal. * body mass index (BMI) ≥40 kg/m2. * History of hypersensitivity to the drugs being evaluated * Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders. * chronic use of opioids and opioid addiction * Patients with acute cholecystitis or converted to open surgery. * Carcinoma of gall bladder * Pregnant female * Bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of first analgesic request. | 24 hours | The primary outcome of the study is comparison of the post-operative analgesic effect regarding the time to first analgesic request of fentanyl versus Ketamine as adjuvants to bupivacaine in patients undergoing laparoscopic cholecystectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total analgesia consumption postoperatively. | 24 hours | Total Nalphuine consumption in milligrams, in the first 24 hours postoperatively. |
| Postoperative Numeric Rating Scale of pain | 24 hours postoperatively. | Postoperative Numeric Rating Scale of pain.( in post-anaesthesia care unit, half hour, 2, 6, 12, 18, 24 hours postoperatively) |
Contacts
CONTACTTarek Mo Essa Tohamy
CONTACTEman Ah Ismail, MD
PRINCIPAL_INVESTIGATORTarek Mo Essa Tohamy
Assiut University
Outcome results
None listed