A Phase 3 interventional study of Bupivacaine Hydrochloride in ERAS, sponsored by King Saud Medical City. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 14 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by King Saud Medical City · Phase 3, Interventional, and Prevention
laparoscopic appendectomy is most common surgical procedure necessitates evidence-based clinical pathways such as Enhanced Recovery After Surgery (ERAS). The paradigm of surgery has been shifted from open to laparoscopic. Laparoscopic appendectomy is the most common procedure performed in our institute for acute and chronic appendicitis. Pain control in ERAS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response, and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in laparoscopic appendectomy patients remains a challenge.
Objectives: To evaluate the efficacy of combined transversus abdominis plane (TAP) and posterior rectus sheath (PRS) blocks on perioperative pain, early mobilization, opioid consumption, Postoperative Nausea \& Vomiting (PONV), length of hospital stay (LOS), patient satisfaction in patients scheduled for laparoscopic appendectomy Methods: 100 patients scheduled for Laparoscopic appendectomy will be recruited in this prospective randomized, blinded clinical study. The patients will be divided into two groups; group-1 (TAP and PRS blocks) (n= 50) will receive intraoperative combined TAP and PRS blocks with bupivacaine 0.25% 2-3 mg/kg, and Group 2 (standard care) (n= 50) will receive standard analgesic protocol in our institute. Intraoperatively, all patients will receive conventional intravenous (IV) analgesics and antiemetics (Paracetamol 1 gram + Lornoxicam 8 mg + Dexamethasone 8mg + Ondansetron 4mg). For breakthrough pain in Post Anesthesia Care Unit (PACU) and ward, all patients will be prescribed for IV PRN (as needed) morphine 2 mg maximum 10 mg, paracetamol 1 gram every 6 hours, lornoxicam 8 mg every 8 hours. During pre-anesthesia assessment patients will be instructed how to use 10 cm numerical rating scale (NRS) (0 cm no pain, 10 cm worse pain) to report pain postoperatively. On arrival to the operation room (OR), all eligible participants will have intravenous (IV) cannula in situ and monitors, according to the Association of Anesthetists of Great Britain and Ireland (AAGBI). Anesthesia will be induced with the following drugs: fentanyl 2mcg/kg, propofol 2mg/kg, followed by rocuronium 1mg/kg to facilitate tracheal intubation. Anesthesia drugs doses will be calculated according to ideal body weight (IBW) and adjusted body weight (AjBW) using this link: https://globalrph.com/medcalcs/adjusted-body-weight-ajbw-and-ideal-body-weight-ibw-calc/. General anesthesia will be maintained with Desflurane Minimum Alveolar Concentration (MAC) value of 0.7-1with Fraction of Inspired Oxygen (FIO2) 45%. Before skin incision, US guide left TAP and bilateral PRS blocks will be performed by the anesthesia consultant/senior registrar. and then at the end of surgical procedure desflurane will be discontinued and 2.5 mg of neostigmine with 0.4 micrograms of glycopyrolate will be given. All patients will be transferred to PACU after tracheal extubation. Patients will be monitored in PACU for hemodynamics, pain measured by NRS, morphine or any other analgesic consumption and for PONV antiemetics will be given as required. And in the ward 2, 6,12 and 24 hourly till discharged to home. Patients will be transferred to the ward from PACU when they achieve modified Aldrete score of 9 on two sequential measurements of 10 minutes' interval. All patients, care providers in PACU \& ward (nurses), and outcome assessors (assistant anesthesiologist) will be blinded to the group allocation. Only the assigned anesthesiologist responsible for perioperative care will be aware of the group allocation to treat any unwanted side effects during and after the operation. And in the ward 2, 6,12 and 24 hourly pain score (NRS) will be assessed till discharged to home.
King Saud Medical City is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
) will receive standard routine postoperative analgesia at our institute.
The patients will be divided into two groups; group-1 (n= 50) will receive pre-procedure right US-guided TAP and bilateral PRS blocks with bupivacaine 0.25% 20 ml for TAP block and 10 ml for PRS block .
Drug: Bupivacaine Hydrochloride
Patients will be randomly assigned to receive a TAP and PRS blocks with 34 mL of 0.25% bupivacaine (study group) or standard hospital analgesia protocol (control group).
Also known as: TRASVERSE ABDOMINIS AND POSTERIOR RECTUS SHEATH BLOCKS
to assess the pain score by verbal numerical rating scale[VNRS]
to assess the pain score by using verbal numerical rating scale \[0-10\]in immediate postop period on arrival in PACU and then after 2,4,6,12 and 24 hours postop.between two groups.Low scores on verbal numerical rating scale will be beneficial factor in early discharge of patients from the hospital.
Time frame: 7 months
opiod consumption
to measure opiods consumption in milligrams\[mg\] during intraop followed in PACU and after 4,6,12 and 24 hours postop.
Time frame: 7 months
early mobility after surgery measured by john hopkins highest level of mobility scale[JH-HLM]
early mobility after surgery measured by john hopkins highest level of mobility scale\[JH-HLM\] this scale is a validated 1-item ordinal scale ranging from lying passively in bed\[score=1\] to walking equal or more than 250 feet \[score=8\] within immediate postop and within 24 hours postop.high scores on mobility scale used indicates early patient mobility and discharge from the hospital.
Time frame: 7 months
to assess the severity of postoperative [PONV] during immediate postop and after 4,6,12 and 24 hours postop.
to assess the severity of postoperative \[PONV\] during immediate postop and after 4,6,12 and 24 hours postop. by using numeral rating scale \[0-10\]for nausea as no for score 0,mild for 1-3,moderate for 4-6, and severe for 7-10 with propensity to vomiting.and document vomiting by yes or no.low scores on verbal numerical rating scale for nausea will be contributing early discharge of the patients from the hospital.
Time frame: 7 months
Plan to share: Undecided
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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King Saud Medical City