Clinical trial NCT05341869: PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY
Official title: PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED PLACEBO CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Total hysterectomy is one of the most common surgical procedure in gynecology. The laparoscopic route for the performance of hysterectomies are on the rise \[1\]. The laparoscopic hysterectomy (TLH) procedure has several advantages over open surgery such as better cosmetic outcomes, faster recovery earlier return to normal activities and work \[1-3\]. Nonetheless, postoperative pain (PP) remains an issue that scuppers these advantages \[1-3\].

The incidence of PP after TLH has been reported to vary from 35% to 63% \[4,5\]. The origin of PP after laparoscopy is multifactorial and complex such as perioperative predicaments, including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the abdomen, and dissection of the pelvic region \[6-7\]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy \[8\]. Further inquiry to intercept the advancement and decrease the severity of PP is prominent to further improve TLH.

Women undergoing TLH experience two different pain characteristics including incisional pain and visceral pain in the first hour after the operation \[6\]. These pains were most intense 30 min after TLH, gradually decreasing thereafter for postoperative 72 hr \[6\]. High levels of acute postoperative pain (APP) are pertain with an increment risk of chronic postsurgical pain so control of these acute pains in the urgent postoperative period is vital for faster amelioration.

Many attempts have been tried to control APP after THL, such as transverse abdominal plane blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and reduced port caliber \[9-12\]. Para-cervical bloc (PCB) is believed to block the Frankenhouser nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the vagina. Only two randomized studies have assessed the effect of PCB in THL, but several limitations such as the small sample size preclude drawing conclusions on PP after TLH. Thus, the primary goal of this randomized clinical trial was to investigate if PCB at the onset of surgery, as a part of enhanced recovery protocol, could improve patient recovery after THL.


Eligibility criteria: Inclusion Criteria:

-Patients undergoing total type A laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy or salpingectomy

Exclusion Criteria:

* age \< 18 years
* refusal to provide consent
* inability to understand the study questionnaire
* severe psychiatric or mental disorder
* American Society of Anesthesiologists (ASA) physical status classification \> III
* history of regular narcotic use within 6 months of the surgery
* conversion to laparotomy
* operation time \> 90 min
* Additional procedures

Primary outcomes:
measure: visual analog scale (VAS) pain score
timeFrame: up to 1 hour after the procedure
Secondary outcomes:
measure: the quality of postoperative recovery
timeFrame: Up to 24 hours after the procedure
measure: faces pain scale-revised score
timeFrame: up to 2,4,6,12 hours after the procedure
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Education and Research Hospital
state: Mentese
city: Menteşe
country: Turkey
facility: Kemal Güngördük
state: Muğla
Study officials:
References: