Efficacy of Pericapsular Nerve Group (PENG) Block for Hip Surgeries

Pain, Postoperative Clinical Trial

Official title: The Impact of Pericapsular Nerve Group Block on The Duration of Post-Operative Analgesia Following Hip Joint Surgeries

Status Recruiting

Clinical Trial Summary

To study the efficacy of the PENG block on the duration of postoperative analgesia. There are two groups of patients, who are undergoing hip joint surgeries, one group (Control Group) will receive spinal anesthesia only while the other group (PENG Group) will receive PENG block before spinal anesthesia.

Clinical Trial Description

Research Question:

Is PENG block effective in prolonging the duration of postoperative analgesia when compared to patients undergoing spinal anesthesia only?

Research Hypothesis:

PENG block is effective in prolonging the duration of postoperative analgesia and reducing postoperative pain.

Aim:

To improve the outcome of hip joint surgeries by decreasing the postoperative pain and early mobilization by performing PENG block to patients undergoing hip joint surgeries.

Method of randomization:

This clinical trial will be randomized through computer software that generates random number table and patients will be allocated randomly to one of the two groups.

Sample size:

The sample size was determined by using the following equation:(Charan J et al. 2013) N =(2 δ^(2 ) 〖(Z_α+ Z_β)〗^2)/D^2 δ=Standard deviation of the outcome = 6.7 (Pascarella et al., 2021). Z_α= The value for a type I error of 5% = 1.96 Z_β=The value for a type II error of 20% = 0.84 D^2= The effect size = 36 (Pascarella et al., 2021).

By calculation:

N = 19 per group. So, the total sample size is 38.

Procedures:

After getting the informed consent from the patient, the patient will be allocated into one of the study groups according to randomization.

ASA standard monitors will be attached to the patient, a wide pore cannula (18G) will be inserted then a premedication with 50 -100 mcg of fentanyl and 1-2 mg midazolam intravenously will be given.

PENG group: PENG block will done under complete aseptic condition with 20 ml 0.25% bupivacaine diluted with normal saline Control group: no block will be done. Both groups will be anesthetized using spinal anesthesia with Bupivacaine

Study Variables:

Independent variables: age, sex, weight, height, body mass index (BMI), elective or emergency surgery, duration of surgery, American Society of Anesthesiologists physical status classification (ASA score), occupation, fracture site, type of trauma, timing (operating room entry- PENG block time- start of spinal anesthesia- start of surgery- end of surgery ).

Dependent variables: Postoperative pain, adverse events, and postoperative motor assessment, hemodynamics, the first request of analgesia & total analgesia required, adverse events such as nausea vomiting & sedation, pain scores at preparation room, after PENG block, during sitting for spinal anesthesia, at end of the surgery, postoperative intervals(rest & movement). ;

Related Conditions & MeSH terms

• Pain, Postoperative

• NCT number: NCT06144931
• Study type: Interventional
• Source: Suez Canal University
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: March 1, 2024