PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY

NCT ID: NCT05341869

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-01-14

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Prior to starting surgery after general anesthesia, the 10 mL of normal saline was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Group Type: PLACEBO_COMPARATOR

Para-cervical block

Intervention Type: PROCEDURE

Block of inferior hypogastric plexus with local anesthetic

Study

Prior to starting surgery after general anesthesia, thE 10 mL of 0.5% bupivacaine with epinephrine was performed by the primary surgeon. The syringe was injected with 5 mL on each side into the cervical stroma at 3 and 9 o'clock with a depth of 2 to 3 cm.

Group Type: EXPERIMENTAL

Para-cervical block

Intervention Type: PROCEDURE

Block of inferior hypogastric plexus with local anesthetic

Interventions

Para-cervical block

Block of inferior hypogastric plexus with local anesthetic

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

Medical Doctor, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, Mentese, Turkey (Türkiye)

Kemal Güngördük

Menteşe, Muğla, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gungorduk K, Gulseren V, Tastan L, Ozdemir IA. Paracervical block before laparoscopic total hysterectomy: A randomized controlled trial. Taiwan J Obstet Gynecol. 2024 Mar;63(2):186-191. doi: 10.1016/j.tjog.2024.01.013.

Reference Type: DERIVED

PMID: 38485313 (View on PubMed)

Other Identifiers

MUGLA-6

Identifier Type: -

Identifier Source: org_study_id