PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

Pain, Postoperative Clinical Trial

Official title:

PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED PLACEBO CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341869
• Other study ID #: MUGLA-6
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 14, 2023

Study information

• Verified date: February 2023
• Source: Erzincan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: January 14, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Para-cervical block
Block of inferior hypogastric plexus with local anesthetic

Locations

Country	Name	City	State
Turkey	Kemal Güngördük	Mentese	Mugla
Turkey	Mugla Sitki Kocman University Education and Research Hospital	Mugla	Mentese

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale (VAS) pain score	1 h postoperative visual analog scale (VAS) pain score	up to 1 hour after the procedure
Secondary	the quality of postoperative recovery	the quality of postoperative recovery according to the QoR-40 questionnaire scores at 24 hours after the surgical procedure	Up to 24 hours after the procedure
Secondary	faces pain scale-revised score	Faces pain scale-revised score is an objective method of pain assessment in which facial expressions of the patient are assessed by the investigator	up to 2,4,6,12 hours after the procedure